Clinical Global Impression Scores Research Articles

Examining Lurasidone Efficacy in Patients with Schizophrenia Spectrum Illness and Concurrent Alcohol and Substance Use Disorder: A Prospective, Multicentric, Real-World Investigation.

Background: Dual disorders (DD) entail the coexistence of a substance use disorder (SUD) and another mental health condition, often within psychotic and affective disorders. This study aims to evaluate lurasidone, an innovative atypical antipsychotic, in individuals diagnosed with schizophrenia spectrum disorder and concurrent comorbidities of alcohol use disorder/substance use disorder (AUD/SUD). Methods: A cohort of 23 subjects diagnosed with schizophrenia spectrum disorder and comorbid AUD/SUD underwent psychometric assessments at baseline (T0) and one-month (T1) post-lurasidone initiation. Results: Lurasidone exhibited significant reductions in psychopathological burden, evidenced by decreased total PANSS scores (Z = 2.574, p = 0.011). Positive symptoms, substance craving (VAS Craving; Z = 3.202, p = 0.001), and aggressivity (MOAS scale; Z = 2.000, p = 0.050) were notably reduced. Clinical Global Impression (CGI) scores significantly improved (Z = 2.934, p = 0.003). Quality of life enhancements were observed in SF-36 subscales (energy, emotional well-being, and social functioning) (p < 0.05) and Q-LES-Q-SF scale (Z = -2.341, p = 0.021). A safety analysis indicated lurasidone's good tolerability, with only 8.7% reporting discontinuation due to side effects. Conclusions: This study offers initial evidence supporting lurasidone's efficacy and safety in dual diagnoses, highlighting positive effects on psychopathology, substance craving, and quality of life. These findings emphasize the need for tailored, comprehensive treatment strategies in managing the complexities of this patient population.

Hydrothermal ablation in recurrent or chronic olecranon bursitis: a prospective study

Olecranon bursitis can be difficult to treat, resulting in persistent or recurrent symptoms. Bursectomy is a frequently applied treatment option for refractory cases but has high complication rates. This is the first invivo study to investigate the safety and efficacy of hydrothermal ablation, a new treatment modality for recurrent or chronic olecranon bursitis that aims to cause thermal obliteration of the bursal lining by irrigation with heated saline. First, a pilot animal trial was set up to determine a safe irrigation temperature window. Second, in a human trial the bursae of patients with chronic, recurrent, or refractory olecranon bursitis were irrigated with a 3-mL/s flow of physiological saline for a duration of 180 seconds at temperatures between 50°C and 52°C. Patients were followed up for 6 months, allowing for assessment of the surgical site to screen for adverse events, volumetric ultrasonographic assessment of the bursae, and collection of the Quick Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH), Patient Global Impression Score, and Clinical Global Impression Score, as well as data on return to activities or work. Twenty-four elbows were prospectively included and underwent a full cycle of hydrothermal ablation. The mean age was 58.4 years (range 40.5-81.5), including 20 male and 4 female patients. None had clinical signs of septic bursitis. Bursal fluid cultures were positive in only 1 case. The average preoperative bursal volume was 11.18 mL (range 4.13-30.75). Eighteen of 24 elbows (75%) were successfully treated, showing a complete remission of symptoms or decided improvement within 6 weeks and without any signs of recurrence during the entire follow-up period of 6 months. The average reduction of ultrasonography-measured bursal volume was 91.9% in the group of patients who responded to treatment. In patients without recurrence, the mean QuickDASH scores before and after treatment were 13.6 (range 0-50) and 3.1 (range 0-27.5), respectively, showing a statistically significant improvement. All patients were able to fully return to work within 6 weeks after the index procedure. No serious adverse events were encountered. Moderate local adverse events were found in 2 patients. Increasing temperatures of irrigation did not result in a higher treatment efficacy. Hydrothermal ablation at temperatures between 50°C and 52°C is a safe treatment option for recurrent or chronic olecranon bursitis with fewer complications than open bursectomy and a comparable efficacy.

Cortisol in functional neurological disorders: State, trait and prognostic biomarkers

ObjectiveBiological stress dysregulation, such as a flattened cortisol awakening response (CAR), has been identified in functional neurological disorder (FND). This longitudinal study aimed to explore whether CAR alterations in FND serve as state or trait biomarkers, assessing temporal changes in cortisol and clinical outcomes to test its prognostic value. MethodsSalivary cortisol was measured in 53 patients with mixed FND at two visits separated by eight months (M0 and M8). CAR was calculated based on five consecutive samples, each taken with 15-min time intervals, collected upon awakening, whereas cortisol amplitude (CAmp) was calculated as the difference between the morning peak and the afternoon trough. Clinical outcome was assessed with the Functional Movement Disorder Rating Scale (S-FMDRS), Clinical global impression (CGI) scores for severity (CGI-S) and improvement (CGI-I) and the short-form health survey (SF-36). ResultsNo differences in CAR levels were found between M0 and M8 regardless of clinical outcome (remained flattened). However, a good clinical outcome was associated with an earlier peak in the CAR (p = .013, odds ratio: 1.78; 95%-confidence interval: 0.095–1.13). A lower CAmp at M0 predicted a better outcome at M8 (β = 1.14, 95%-confidence interval:0.15–2.13, p = .03). ConclusionA flattened CAR might represent a trait marker for FND, when an earlier peak in the CAR may serve as a state biomarker. The CAmp demonstrates predictive power for clinical outcome, potentially representing a prognostic biomarker for FND. Further replication and follow-up studies are essential to confirm this suggested role of cortisol as a multifaceted biomarker of FND.

Internet Gaming Disorder in Children and Adolescents with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder.

Attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) have been related to an increased risk for behavioral addictions including online gaming. However, the relationship between these two conditions and Internet gaming disorder (IGD) is still debated. The aim of this study is to address this topic by exploring the prevalence of IGD in a consecutive sample of ASD youth and ADHD youth, compared with a normal control group, and by assessing selected psychopathological and neuropsychological features in ASD and ADHD patients with and without IGD. This study included 77 ASD patients (67 males, mean age 13.58 ± 2.75 years), 94 ADHD patients (79 males, mean age 11.46 ± 2.47 years), and 147 normal controls (NC) (mean age 13.9 ± 3.0 years, 114 males) that received structured measures for IGD (IAT, IGDS9-SF, and UADI). In the ADHD group, 72.34% of the sample were above the IGD cut-off, compared with 45.45% in the ASD group and 9.5% in the NC group. ASD patients with IGD presented with greater severity and more severe attention problems, with no difference in the ASD core symptoms between patients with and without IGD. In the comparison between the ASD and ADHD groups according to the presence of IGD, ASD patients with IGD were the most severe group according to the CGI (Clinical Global Impression) scale. The follow-up, conducted on 45 patients affected by ASD, showed an improvement in CGI and CGAS (Children's Global Assessment Scale) scores, but not in the IGD symptoms. These findings could place the diagnosis of ASD as a negative prognostic factor in the follow-up of aspects of video game addiction compared with ADHD.

Active versus sham DLPFC-NAc rTMS for depressed adolescents with anhedonia using resting-state functional magnetic resonance imaging (fMRI): a study protocol for a randomized placebo-controlled trial

BackgroundAnhedonia, which is defined as the inability to feel pleasure, is considered a core symptom of major depressive disorder (MDD). It can lead to several adverse outcomes in adolescents, including heightened disease severity, resistance to antidepressants, recurrence of MDD, and even suicide. Specifically, patients who suffer from anhedonia may exhibit a limited response to selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy (CBT). Previous researches have revealed a link between anhedonia and abnormalities within the reward circuitry, making the nucleus accumbens (NAc) a potential target for treatment. However, since the NAc is deep within the brain, repetitive transcranial magnetic stimulation (rTMS) has the potential to modulate this specific region. Recent advances have enabled treatment technology to precisely target the left dorsolateral prefrontal cortex (DLPFC) and modify the functional connectivity (FC) between DLPFC and NAc in adolescent patients with anhedonia. Therefore, we plan to conduct a study to explore the safety and effectiveness of using resting-state functional connectivity magnetic resonance imaging (fcMRI)-guided rTMS to alleviate anhedonia in adolescents diagnosed with MDD.MethodsThe aim of this article is to provide a study protocol for a parallel-group randomized, double-blind, placebo-controlled experiment. The study will involve 88 participants who will be randomly assigned to receive either active rTMS or sham rTMS. The primary object is to measure the percentage change in the severity of anhedonia, using the Snaith-Hamilton Pleasure Scale (SHAPS). The assessment will be conducted from the baseline to 8-week post-treatment period. The secondary outcome includes encompassing fMRI measurements, scores on the 17-item Hamilton Rating Scale for Depression (HAMD-17), the Montgomery Asberg Depression Rating Scale (MADRS), the Chinese Version of Temporal Experience of Pleasure Scale (CV-TEPS), and the Chinese Version of Beck Scale for Suicide Ideation (BSI-CV). The Clinical Global Impression (CGI) scores will also be taken into account, and adverse events will be monitored. These evaluations will be conducted at baseline, as well as at 1, 2, 4, and 8 weeks.DiscussionIf the hypothesis of the current study is confirmed, (fcMRI)-guided rTMS could be a powerful tool to alleviate the core symptoms of MDD and provide essential data to explore the mechanism of anhedonia.Trial registrationClinicalTrials.gov NCT05544071. Registered on 16 September 2022.

A comparative study to assess the efficacy and cost-effectiveness of amisulpride versus olanzapine in schizophrenia patients at psychiatry outpatient department

Background: Among psychiatric illnesses, schizophrenia remains a chronic debilitating disorder. Although newer atypical antipsychotics have shown better improvement in schizophrenia patients, they are still lacking conclusive evidence-based studies. Aims and Objectives: The comparative evaluation of amisulpride versus olanzapine in terms of therapeutic efficacy and their cost in schizophrenia patients. Materials and Methods: This was a prospective, randomized, open-label comparative study. Patients diagnosed with schizophrenia were randomly allocated into two treatment arms. One group (n = 50) was treated with olanzapine, and another group (n = 50) was treated with amisulpride. Patients were followed up for 12 weeks. Positive and negative syndrome scale score assessments were done to evaluate the efficacy parameter. Antipsychotic drug costs were also studied. Results: In the treatment duration, it was observed that the positive and negative syndrome scores were 42.7% in the olanzapine-administered group, whereas the score was 33.8% in patients treated with amisulpride. The reduction in clinical global impression (CGI) score was 57% in the olanzapine group and 37% in the amisulpride group. The cost range for amisulpride was (Rs) 52.5–115.9 and for olanzapine was (Rs) 6.7–13.1 per positive and negative syndrome score improvement. Conclusion: A significant decrease in positive and negative syndrome scores and CGI scores was evident in both groups treated with amisulpride and olanzapine, but olanzapine is more efficacious and cost-effective than amisulpride.

Effect of Tiaoxie Yizhi Formula combined with atomoxetine and biofeedback therapy of school-age children with attention deficit hyperactivity disorder

Purpose: To investigate the effect of Tiaoxie Yizhi Formula combined with atomoxetine and biofeedback therapy on the Swanson, Nolan, and Pelham-IV Rating Scale (SNAP-IV) score as well as Clinical Global Impression (CGI) score of school-age children with attention deficit hyperactivity disorder (ADHD).Methods: Clinical data of 85 school-age children with ADHD who were admitted to Dushu Lake Hospital from April 2019 to June 2022 were analyzed retrospectively. Patients treated with biofeedback therapy and atomoxetine for 1 month were defined as control group (n = 42), while those treated with Tiaoxie Yizhi Formula in addition to what was given control group were defined as study group (n = 43). Efficacy, Traditional Chinese Medicine (TCM) symptom scores, SNAP-IV score, CGI score and cerebral electrophysiological indices were compared between the groups. The scores of the main and secondary syndromes were also compared between two groups.Results: Treatment response rate in study group was significantly higher than in control group (p &lt; 0.05). There was no significant difference in scores of the main syndromes and secondary syndromes, SNAP-IV score or CGI score between the two groups before treatment (p &gt; 0.05). However, scores of the two groups decreased significantly after treatment, and study group had significantly lower scores than control group (p &lt; 0.05). There was no significant difference in sensorimotor rhythms (SMR) waves, β waves, or θ waves between the two groups before and after treatment (p &gt; 0.05).Conclusion: Tiaoxie Yizhi Formula plus atomoxetine plus biofeedback therapy improves ADHDsymptoms more tha n biofeedback therapy and atomoxetine combination as shown by the reduction in TCM, SNAP-IV and CGI scores. However, investigations will need to be carried out using a larger sample size in order to validate these findings.

Feasibility Study of Virtual Reality-Based Cognitive Behavioral Therapy for Patients With Depression: Protocol for an Open Trial and Therapeutic Intervention.

The clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it. We aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression. This is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post-comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device.Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR's feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months. Participant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023. This study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study. Japan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481. DERR1-10.2196/49698.

Acute Taste Dysfunction in Oropharyngeal Cancer Patients after Transoral Robotic Surgery.

To compare taste changes after transoral robotic surgery (TORS) to taste changes in healthy controls. Oropharyngeal cancer patients receiving TORS and healthy controls were recruited. Participants underwent posterolateral and whole-mouth psychophysical taste testing (identification, intensity, and hedonics) at baseline and at 2 weeks postoperatively (patients) or follow-up (controls). Surgeons reported suspension time and glossopharyngeal nerve injury (GNI) based on the identification and sacrifice of the nerve. A Clinical Global Impression (CGI) of taste symptoms was completed at each session ("My sense of taste bothers me" on a 5-point scale from Never [1] to Always [5]). A taste disorder (TD) was a CGI of 3 (Sometimes) or worse. Within-subject changes in CGI and psychophysical scores were computed. "Worsened taste" was a CGI increase by ≥1 point at follow-up. Of 69 participants, most (33/37 tumor, 31/32 controls) had normal baseline taste (CGI < 3). 14/33 (42%) TORS patients and no controls developed new TDs at follow-up. More smokers (7/9) had worsened taste than nonsmokers (19/60, difference = 46% [95% CI 16%-76%]). More patients without GNI (6/22) than with GNI (0/15) had postoperative phantogeusia (difference = 27% [95% CI 9-45%]). Tumor-ipsilateral taste identification (TI) decreased more in patients (-11.3%) than controls (0.8%, difference = 12.2% [95% CI 5.0-19.3%]). Suspension time was not associated with worsened taste symptoms or psychophysical changes. Patient-reported taste changes after TORS are frequent. Compared to healthy controls, TORS patients have decreased tumor-ipsilateral TI. Suspension time and GNI are unlikely to cause symptomatic TDs. Further investigations of the etiology and long-term symptom burden of TORS-associated TDs will aid in the management of oropharyngeal cancer patients. 3 (non-randomized controlled cohort study) Laryngoscope, 133:3520-3528, 2023.

Migraine in bipolar disorder and schizophrenia; The hidden pain.

This study examined the prevalence of comorbid migraine in patients with bipolar disorder and those with schizophrenia and also examined the association between migraine comorbidity and disease characteristics of both psychiatric disorders. In this cross-sectional study, 150 patients with bipolar disorder and 150 with schizophrenia were evaluated for migraine diagnosis using the International Classification of Headache Disorders (3rd ed). Patients were selected from psychiatry outpatient clinics at Kasr Al Ainy hospitals, Cairo University. The Young Mania Rating Scale (YMRS) and the Hamilton Depression Rating Scale (HDRS) were administered to the bipolar group, whereas the Positive and Negative Syndrome Scale (PANSS) was administered to the schizophrenia group. Both groups were evaluated by the Clinical Global Impression (CGI) scale. The diagnosis of migraine was made in 34 (22.7%) of the bipolar group and 24 (16.0%) of the schizophrenia group. Patients with schizophrenia showed a significantly higher frequency and intensity of migraine attacks on the Migraine Disability Assessment scale than did the bipolar group (p < 0.001). In the bipolar group, there was no significant difference between patients with and without migraine on the YMRS, HDRS, and CGI. Among patients with schizophrenia, the duration of the migraine attacks was positively correlated with CGI scores (r = 0.40, p = 0.02). Migraine is a significant comorbidity in patients with bipolar disorder and schizophrenia.However, the intensity and frequency of migraine attacks were higher in the schizophrenia than in the bipolar group.

Effects of increased body mass index on one year outcomes following soft tissue arthroscopic shoulder instability repair

The purpose of this study was to investigate the impact of high body mass index on the 1-year minimal outcome following arthroscopic shoulder stabilization. Patients who underwent arthroscopic Bankart repair (ABR) between 2017 and 2021 were identified and assigned to 1 of 3 cohorts based on their preoperative body mass index: normal (18-25), overweight (25-30), and obese (>30). The primary outcomes assessed were postoperative shoulder instability and revision rates. The 3 groups were compared using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper extremity, pain interference, pain intensity, Clinical Global Impression scores, visual analog scale pain scores, and shoulder range of motion at 1 year postoperatively. During the study period, 142 patients underwent ABR and had an average age of 35±10 years. Obese patients had a higher percentage of partial rotator cuff tears (60% vs. 27%, odds ratio: 3.2 [1.1, 9.2]; P=.009), longer mean operative time (99.8±40.0 vs. 75.7±28.5 minutes; P<.001), and shorter time to complication (0.5±0 vs. 7.0±0 months; P=.038). After controlling for confounding factors, obesity was associated with a lesser improvement in upper extremity function scores (obese vs. normal:-4.9 [-9.4,-0.5]; P=.029); although this difference exists, found future studies are needed to determine the clinical significance. There were no differences in patient reported outcome measures, recurrence rate, or revision surgery rates between cohorts at any time point (P>.05). Obesity is an independent risk factor for longer operative times but does not confer a higher risk of recurrent instability, revision surgery, or lower outcome scores 1 year following ABR.

Efficacy and safety of fixed-dose combination of Bilastine-Montelukast in adult patients with allergic rhinitis: a phase III, randomized, multi-center, double-blind, active controlled clinical study

Background Histamine and cysteinyl leukotrienes (CysLTs) are potent inflammatory mediators in allergic rhinitis (AR). Studies involving other combinations of antihistaminics (Levocetirizine) and highly selective leukotriene receptor antagonist (LTA) (Montelukast) combination have shown additive benefits and are widely prescribed for AR. Objective Evaluate the efficacy and safety of Bilastine 20 mg and Montelukast 10 mg fixed-dose combination (FDC) therapy in patients with AR. Methods A randomized, double-blind, comparative, parallel, phase III study was conducted to evaluate efficacy and safety of Bilastine 20 mg and Montelukast 10 mg FDC at 16 tertiary care otolaryngology centres in India. Adult patients with AR for one year with IgE antibody positive and 12-h NSS score >36 in 3 days were randomized to receive either Bilastine 20 mg and Montelukast 10 mg or Montelukast 10 mg & Levocetirizine 5 mg tablets for 4 weeks. The change in total symptom score (nasal symptom scores (NSS) & non-nasal symptom scores (NNSS)) from baseline to week 4 was assessed as primary endpoint. Secondary endpoints included changes in TSS, NSS, NNSS, individual symptom scores (ISS), Rhinoconjunctivitis Quality of Life (RQLQ), discomfort due to rhinitis (VAS), and clinical global impression (CGI) scores. Results The change in mean TSS from baseline to week 4 in Test group (16.6 units) was comparable to reference group (17 units) (p= 0.8876). The difference in change in mean NSS, NNSS and ISS from baseline to day 7, 14, 28 were comparable. RQLQ improved from baseline to Day 28. Significant improvements were observed in discomfort due to AR measured by VAS and CGI scores from baseline to day 14 and 28. The safety and tolerability of patients were comparable between the groups. All adverse events (AEs) were mild to moderate in severity. No patient discontinued due to AEs. Conclusions The FDC of Bilastine 20 mg and Montelukast 10 mg was efficacious and well tolerated in Indian patients with AR.

Ictal Electroencephalogram Visual Pattern Recognition of Seizure Adequacy During Electroconvulsive Therapy Treatment: A Step-by-Step Approach.

The NEURON (Neuropsychiatry and Neuromodulation Unit) electroconvulsive therapy electroencephalogram (ECT-EEG) Algorithmic Rating Scale (NEARS) is a step-by-step approach to ictal electroencephalogram visual pattern recognition of seizure adequacy based on recruitment, amplitude, symmetry, duration and degree of post-ictal suppression. The objectives of this clinical audit were to determine the degree of agreement on the NEARS operational criteria between two neuropsychiatrists, the reliability of electroconvulsive therapy practitioners' administration of NEARS during ECT procedures and the correlation of NEARS scores with Clinical Global Impression scale scores after each ECT treatment session. Systematic random sampling was conducted. Even numbers of ictal tracings were selected for analysis from the total samples collected over 8 consecutive days of ECT overseen by a total of eight different ECT practitioners. Cohen's kappa coefficient was used to measure the inter-rater reliability of the two neuropsychiatrists and determine the level of agreement between NEARS scores and those of the ECT practitioners. The correlation using NEARS scores and post-ECT Clinical Global Impression scores was measured with Spearman's test. The significance level was set at P < 0.05. Cohen's kappa showed perfect agreement between the two neuropsychiatrists, at κ = 1.00 (SE = 0.001; P < 0.001), and strong agreement between NEARS scores of overall seizure adequacy and the scores interpreted by the ECT practitioners, at κ = 0.83 (95% CI: 0.66, 0.99; P < 0.001). Spearman's test showed a weak negative association between NEARS scores and post-ECT Clinical Global Impression scores (r = -0.018; P = 0.900). NEARS may facilitate a brief, objectively reliable and practical assessment of ictal electroencephalogram quality. The scale is readily applicable by any trained ECT practitioner during an ongoing ECT procedure, especially when a prompt treatment decision is required.

Effectiveness of Switching to Long-acting Injectable Aripiprazole in Patients with Recent-onset and Chronic Schizophrenia.

This study investigated the effectiveness of switching to once-monthly long-acting injectable (LAI) aripiprazole from other second-generation antipsychotics including LAI paliperidone palmitate in both recent-onset and chronic schizophrenia patients. This was a 24-week prospective, open-label, flexible dose-switching study in patients with schizophrenia. Scores on the Positive and Negative Syndrome Scale (PANSS), Personal and Social Performance (PSP) scale, Clinical Global Impression (CGI), Subjective Well-being Under Neuroleptics-Short Form (SWN-K), and a computerized emotional recognition test (ERT) were evaluated. Subjects were divided into two groups (recent onset and chronic) based on 5 years' duration of the illness. Among the 82 patients participating, 67 (81.7%) completed the 24-week study. The discontinuation rate after switching to LAI aripiprazole did not differ according to clinical characteristics including type of previous antipsychotics. Scores on the PANSS, PSP, SWN-K, CGI, and ERT were significantly improved after a switch to LAI aripiprazole without exacerbation of metabolic parameters and bodyweight. The improvements in the PANSS, PSP, and CGI scores were significantly greater in patients with recent-onset than in those with chronic schizophrenia; the improvement in metabolic parameters was significantly greater in the latter group. High rates of successful switching to LAI aripiprazole from other antipsychotics suggest its good tolerability and effectiveness. Improvements in psychopathology and social functioning were more evident in patients with recent- onset schizophrenia, and improvements in metabolic abnormalities were more prominent in patients with chronic schizophrenia.

A multicenter, randomized, double blind, placebo-controlled clinical trial of dl-3-butylphthalide in treatment of amyotrophic lateral sclerosis.

A multicenter, randomized, double blind, placebo-controlled clinical trial of dl-3-butylphthalide in treatment of amyotrophic lateral sclerosis.

The effect of adding curcumin to sodium valproate in treatment of patients with bipolar disorder in the acute phase of mania: A randomized double-blind clinical trial.

Inflammatory processes play a role in the etiopathogenesis of bipolar disorder type 1. Full therapeutic responses are seldom seen and the ongoing inflammatory processes in the brain could lead to neuronal loss. Curcumin, a relatively safe herbal compound, has been shown to have anti-inflammatory effects. The present randomized double-blind clinical trial study aimed to investigate the effect of adding curcumin to the treatment regimen of BID. This randomized double-blind clinical trial was conducted on 78 patients diagnosed with BID according to the Diagnostic and Statistical Manual of Mental Disorders (DSM 5) criteria. The sample were divided into two groups. Patients in both groups received sodium valproate starting at a dose of 600 milligrams per day and administered up to 20 milligrams per kilogram per day or the highest dosage of the patient's tolerance. Patients in the intervention group also received curcumin as nanomicelle in soft gelatin capsules 40 milligrams per day. The control group received placebo tablets with the same characteristics as the curcumin tablets. They were assessed by a psychiatrist using the Young Mania Rating Scale (YMRS), Mini-Mental State Examination (MMSE), Clinical Global Impression (CGI), and a medication side effect questionnaire at the beginning of the study, as well as in the first, second, and fourth weeks of the study. Among the 78 patients chosen to participate in the project, 54 people completed the trial. No specific side effect was observed in the two groups. Both groups showed an increase in their MMSE scores compared to the beginning of the study (value of p < 0.001). Although this increase was not statistically different between the two groups (value of p = 0.68). The YMRS score of both groups decreased significantly by the end of the study (value of p < 0.001); however, this decrease was not significantly different between the two groups (value of p = 0.64). In addition, the two groups experienced a significant increase in their CGI scores throughout the study (value of p < 0.001), this increase however was not statistically different between the two groups (value of p = 0.88). The present study suggested that curcumin may not be a useful adjuvant agent in the management of patients with BID receiving sodium valproate as treatment.Clinical trial registration: Iranian Registry of Clinical Trials (IRCT), identifier IRCT2016102530504N1.

An open-label study of oral acetazolamide for the prevention of antipsychotic associated weight gain

Weight gain associated with atypical antipsychotic medications need to be well managed. We set out: 1. To test the effect of acetazolamide on weight gain associated with antipsychotics 2. To assess improvement in psychotic symptoms using the Brief Psychiatric Rating Scale score on patients receiving acetazolamide. This open-label study conducted after institutional ethical clearance from December 2018 to August 2020 included 34 drug-naive patients or patients on antipsychotic risperidone or olanzapine for less than one month. They were divided into two groups of 17 each as a case group (treatment as usual + acetazolamide) and a control group (treatment as usual) who were followed up for eight weeks. The patient's physical characteristics were recorded at baseline and during follow-ups. The Brief psychiatric rating scale (BPRS) and clinical global impression (CGI) scores were compared for the cases and controls. The study showed non-significant reduction in the weight (-0.57 ± 1.06 kg), body mass index (BMI) (-0.23 ± 0.76 kg/m2) and abdominal circumference (-0.47 ± 1.37 cm) in the patients receiving oral acetazolamide at the end of two months as compared to controls where there was significant increase in the weight (+2.62 ± 1.09 kg), BMI (+1.03 ± 0.44 kg/m2) and abdominal circumference (+2.21 ± 1.33 cm, P = 0.001). Similarly, the BPRS and CGI scores were significantly reduced in both arms, with satisfaction rates better among the cases compared to controls. There was a non-significant reduction in the weight, body mass index, abdominal circumference, and brief psychiatric rating scale scores in patients treated with acetazolamide.Ethics committee protocol number: - 2018/244CTRI India registration number: CTRI/2019/05/018884.

Clinical Management of Acral Lick Dermatitis in Dogs with Comparison of Fluoxetine and Clomipramine Treatment

Background: Acral lick dermatitis is defined as self inflicted skin disorder in dogs which induces localized alopecia and fibrotic lesion due to repetitive licking or chewing at the same ‘site most commonly near carpus or hock areas. Methods: The present study was carried out to investigate the approach to the management of various etiologies associated with ALD in dogs. A total of 30 dogs that were diagnosed with acral lick dermatitis (ALD) were rated on the day 0 of theirvisit to the hospital on the basis of three clinical scalesie; ALD severity scale, clinical global impression (CGI) and likert scale. Assessment and weekly rating of the ALD lesion was done during the entire treatment trial. Result: Dogs positive for psychogenic primary triggers were randomly divided in Group 1 (n=9; 47.36%) and Group 2 (n=10; 52.63%). Dogs in group 1 were treated with fluoxetine and dogs in group 2 were treated with clomipramine. Whereas dogs diagnosed with organic triggers were treated empirically. Dogs treated under group 1 exhibited significant difference (p less than 0.05) in the licking and ALD score values at the end of the trial, however, CGI score values were found to be non significant (p greater than 0.05) with mean recovery in 24±2 days and recurrence rate of 44.44% after mean 105±47 days of their treatment completion. 33.33% dogs were also reported with adverse effects of drug as drowsiness in group 1. Dogs treated under group 2 exhibited significant difference (p less than 0.05) in pre and post treatment values of all 3 scores (licking score, ALD score and CGI score) at the end of the trial with mean recovery in 41±5 days and 55.55% cases were reported with signs of reoccurrence after mean 37±21 days of their treatment completion. Total 2(20%) dogs out of ten were presented with adverse effects; 1(10%) with loss of appetite and 1(10%) was reported with vomiting. Both clomipramine and fluoxetine are effective in treating psychogenic triggers of ALD. However, fluoxetine helps in early recovery with lesser recurrence rates whereas clomipramine having better recovery rate with fewer side effects.

The Effect of Agomelatine in Behavioral and Psychological Symptoms of Dementia.

Moderate and severe behavioral and psychological symptoms of dementia (BPSD) often need medical treatment to improve symptoms. Agomelatine is a selective melatonergic (MT1/MT2) agonist that has normalizing effects on disturbed circadian rhythms and disrupted sleep-wake cycles. Its activity of 5HT-2C receptor antagonism is associated with lessening depression and anxiety and increasing slow-wave sleep. Based on past clinical records and current findings it suggests that agomelatine can improve BPSD for patients. This retrospective cohort study was designed to compare the BPSD before and after using agomelatine. Records of dementia cases who had ever received agomelatine treatment for BPSD in a general hospital setting during the past 2.5 years were identified and reviewed. Scores from before and after 3 months of treatment with agomelatine were collected for Neuropsychiatric Inventory (NPI), Brief Psychiatric Rating Scale (BPRS), and Clinical Global Impression (CGI) to compare and analyze the difference of psychological and behavioral symptoms pre- and post-agomelatine used. Records of 144 cases of dementia with BPSD who had ever used agomelatine from January 2015 to June 2017 were collected. All of the 112 cases had BPRS and CGI scores, of which 75 cases had additional NPI scores. Among these 112 cases, the BPRS and CGI scores were significantly improved in all types of dementia. NPI scores indicated that the use of agomelatine alleviated obvious symptoms and decreased overall distress, especially in the depression/poor mood, anxiety, and sleep/night behavior. It is consistent with an effective result of agomelatine in improving BPSD.

A double-blind, randomized, placebo-controlled, single-center clinical trial of jiaotaiwan for the treatment of insomnia symptoms caused by disharmony of the heart and kidney.

Background: Jiaotaiwan (JTW) is a classical tranquillizing prescription in traditional Chinese medicine (TCM) for the treatment of insomnia symptoms caused by disharmony of the heart and kidney (ISDHK). This study aimed to evaluate the effectiveness and safety of JTW for treating ISDHK in a double-blind, randomized, placebo-controlled trial. Methods: From September 2018 to February 2020, 128 participants with ISDHK were included in this single-center clinical trial. All participants were equally and randomly divided into either the JTW group (2-g JTW granules, b.i.d. for 7days) or placebo group (2-g placebo granules, b.i.d. for 7days). Pittsburgh Sleep Quality Index (PSQI) scores were set as the primary outcome, and polysomnography (PSG), 1H-magnetic resonance spectroscopy (1H-MRS), blood tests, and Disharmony of Heart and Kidney Scoring System (DHKSS) and clinical global impression (CGI) scores were used as secondary outcomes. Laboratory tests were used to evaluate the safety of JTW. All data were collected at baseline and posttreatment. Results: A total of 106 participants completed this clinical trial. Symptom relief was more apparent in the JTW group than the placebo group (PSQI total score: 9.34 ± 3.578 vs. 10.98 ± 3.073, respectively; p = 0.006). However, no PSG changes were observed between the two groups (p > 0.05). Higher CGI and lower DHKSS scores were observed after JTW treatment. Serum melatonin was increased in patients with ISDHK after JTW treatment (JTW, 339.09 ± 256.894 vs. placebo, 219.59 ± 169.045; p = 0.004). There were significant posttreatment differences in metabolites in the left cerebellum between the two groups (myoinositol: JTW, 13.47 ± 2.094 vs. placebo, 12.48 ± 2.449; p = 0.021; choline: JTW, 3.96 ± 0.657 vs. placebo, 3.65 ± 0.562; p = 0.008). In terms of safety, JTW had no noticeable adverse effects relative to placebo. Conclusion: JTW was effective and well tolerated for the treatment of ISDHK. The development of large-scale trials with longer follow-up durations is recommended to provide further evidence. Clinical Trial Registration: clinicaltrials.gov, identifier ChiCTR1800019239.