Clinical Global Impression-Severity Scale Research Articles

Clinical Effects of Lisdexamfetamine and Mixed Amphetamine Salts Immediate Release in Adult ADHD: Results of a Crossover Design Clinical Trial

Objectives: To examine the clinical effects of equivalent doses of single-blind (SB; patient-blind) lisdexamfetamine (LDX) and mixed amphetamine salts-immediate release (MAS-IR) on adult attention-deficit/hyperactivity disorder (ADHD) in a placebo (PBO)-controlled, crossover design. Methods: Twenty-four subjects were treated sequentially in a fixed order with (1) SB PBO (matching LDX) for 1 week, (2) SB LDX (up to 70 mg/day) for 5 weeks, (3) SB PBO washout for 3 weeks, and (4) open-label treatment MAS-IR (tid up to 45 mg/day) for 5 weeks. Clinical effects on ADHD and executive function were assessed weekly throughout the trial with the ADHD Rating Scale with adult prompts, the Clinical Global Impression Severity Scale (CGI-S), and the Behavior Rating Inventory of Executive Function (BRIEF). Results: Lisdexamfetamine and MAS-IR were generally well tolerated. Significant and equal reductions on ADHD clinician ratings were seen. Significantly greater reductions in CGI-S and selected BRIEF subsets were observed in LDX over MAS-IR treatment. However, in general, baseline scores for MAS-IR treatment did not fully return to the LDX baseline. Adherence in this structured and monitored clinical trial was good for once daily LDX and 3 times a day MAS-IR. Conclusions: In this crossover study, both LDX and MAS-IR had significant effects on ADHD clinician ratings and measures of executive function (with response rates of about 80%); patients in this monitored clinical trial were adherent with once daily LDX and 3 times a day MAS-IR, which may not be the case in real-world clinical practice. The findings of some superiority of LDX over MAS-IR on the CGI-S and BRIEF ratings may be influenced by the variability in the baselines used, but nevertheless should be further investigated in larger scale, parallel-design clinical trials.

The Spanish version of the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16): A psychometric analysis in a clinical sample

BackgroundPsychometrically robust and easy-to-administer scales for depressive symptoms are necessary for research and clinical assessment. This is a psychometric study of the Spanish version of the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) in a clinical sample. MethodOne-hundred and seventy-three patients (65% women) with a psychiatric disorder including depressive symptoms were recruited. Such symptoms were assessed by means of the QIDS-SR16 and two interviewer-rated instruments: the 17-item Hamilton Depression Rating Scale (HDRS17) and the Clinical Global Impression-Severity (CGI-S) scale. Self-rated measures of health-related quality of life, subjective happiness and perceived social support were also obtained. Dimensionality, internal consistency, construct validity, criterion validity, and responsiveness to change of the QIDS-SR16 were examined. ResultsExploratory and confirmatory factor analyses replicated the original one-factor structure. The Spanish version of the QIDS-SR16 showed good to excellent internal consistency (α=0.88), convergent validity [HDRS17 (r=0.77), CGI-S (r=0.78)], and divergent validity [EuroQol-5D Visual Analogue Scale (r=−0.78), Subjective Happiness Scale (r=−0.72)]. The QIDS-SR16 was excellent in discriminating clinically significant from non-significant depressive symptomatology (area under ROC curve=0.93). It also showed a high sensitivity to treatment-related changes: patients with greater clinical improvement showed a greater decrease in QIDS-SR16 scores (p<0.001). LimitationsThe study was conducted in a single center, which may limit the generalizability of the findings. ConclusionsThe Spanish version of the QIDS-SR16 retains the soundness of metric characteristics of the original version which makes the scale an invaluable instrument to assess depressive symptoms.

Abstinence phenomena of chronic cannabis-addicts prospectively monitored during controlled inpatient detoxification: Cannabis withdrawal syndrome and its correlation with delta-9-tetrahydrocannabinol and -metabolites in serum

ObjectiveTo investigate the course of cannabis withdrawal syndrome (CWS) within a controlled inpatient detoxification setting and to correlate severity of CWS with the serum-levels of delta-9-tetrahydrocannabinol (THC) and its main metabolites 11-hydroxy-delta-9-tetrahydrocannabinol (THC-OH) and 11-nor-delta-9-tetrahydrocannabinol-9-carboxylic acid (THC-COOH). MethodsThirty-nine treatment-seeking chronic cannabis dependents (ICD-10) were studied on admission and on abstinent days 2, 4, 8 and 16, using a CWS-checklist (MWC) and the Clinical Global Impression-Severity scale (CGI-S). Simultaneously obtained serum was analysed to its concentration of THC, THC-OH and THC-COOH. ResultsMWC peaked on day 4 (10.4±4.6 from 39 points) and declined to 2.9±2.4 points on day 16. Women had a significantly stronger CWS than men. The CWS was dominated by craving>restlessness>nervousness>sleeplessness. CGI-S peaked with 5 out of 7 points. On admission, THC and its metabolites did negatively correlate with the severity of CWS. There was no significant correlation afterwards, no matter if CWS was medicated or not. THC-OH in serum declined most rapidly below detection limit, on median at day 4. At abstinence day 16, the THC-levels of 28.2% of the patients were still above 1g/ml (range: 1.3 to 6.4ng/ml). ConclusionsCWS increased and then decreased without any correlation between its severity and the serum-levels of THC or its main metabolites after admission. According to the CGI-S, most patients achieved the condition of ‘markedly ill’. Serum THC-OH was most clearly associated with recent cannabis use. Residual THC was found in the serum of almost one-third of the patients at abstinence day 16.

A pilot controlled trial of a combination of dense cranial electroacupuncture stimulation and body acupuncture for post-stroke depression.

BackgroundOur previous studies have demonstrated the treatment benefits of dense cranial electroacupuncture stimulation (DCEAS), a novel brain stimulation therapy in patients with major depression, postpartum depression and obsessive-compulsive disorder. The purpose of the present study was to further evaluate the effectiveness of DCEAS combined with body acupuncture and selective serotonin reuptake inhibitors (SSRIs) in patients with post-stroke depression (PSD).MethodsIn a single-blind, randomized controlled trial, 43 patients with PSD were randomly assigned to 12 sessions of DCEAS plus SSRI plus body electroacupuncture (n = 23), or sham (non-invasive cranial electroacupuncture, n-CEA) plus SSRI plus body electroacupuncture (n = 20) for 3 sessions per week over 4 weeks. Treatment outcomes were measured using the 17-item Hamilton Depression Rating Scale (HAMD-17), the Clinical Global Impression - Severity scale (CGI-S) and Barthel Index (BI), a measure used to evaluate movement ability associated with daily self-caring activity.ResultsDCEAS produced a significantly greater reduction of both HAMD-17 and CGI-S as early as week 1 and CGI-S at endpoint compared to n-CEA, but subjects of n-CEA group exhibited a significantly greater improvement on BI at week 4 than DCEAS. Incidence of adverse events was not different in the two groups.ConclusionsThese results indicate that DCEAS could be effective in reducing stroke patients’ depressive symptoms. Superficial electrical stimulation in n-CEA group may be beneficial in improving movement disability of stroke patients. A combination of DCEAS and body acupuncture can be considered a treatment option for neuropsychiatric sequelae of stroke.Trial registrationhttp://www.clinicaltrials.gov, NCT01174394.

Observational Study of IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm (XCiDaBLE): Interim Results for the First 170 Subjects with Blepharospasm.

BackgroundXCiDaBLE is a large, prospective, observational “naturalistic” study evaluating Xeomin® for Cervical Dystonia or BLEpharospasm in the United States. We report the interim results from the blepharospasm cohort of XCiDaBLE.MethodsSubjects (≥18 years old) with blepharospasm were followed for two treatment cycles of incobotulinumtoxinA and monitored for 4 weeks after injection via interactive voice/web response system (IVRS/IWRS). The investigator-reported scale includes the Clinical Global Impression Scale-Severity subscale (CGI-S). Patient-reported outcome measures include the Patient Global Impression Scale-Severity (PGI-S) and -Improvement (PGI-I) subscales, Jankovic Rating Scale (JRS), SF-12v2® health survey, and Work Productivity and Activity Impairment questionnaire. Subjects are seen by the investigator at baseline (including the first injection), during the second injection, and at a final study visit (12 weeks after the second injection).ResultsOne hundred seventy subjects were included in this interim analysis. The majority of subjects were female (77.1%) and white (91.8%), and had previously been treated with botulinum toxins (96.5%). The mean total dose (both eyes) was 71.5 U of incobotulinumtoxinA for the first injection. PGI-S, PGI-I, and JRS scores were significantly improved 4 weeks after treatment (all p<0.0001). No differences were noted in either quality of life (QoL) or work productivity in this short assessment period. No unexpected adverse events occurred.DiscussionThis is an interim study and assessment method based on an IVRS/IWRS. In this predominantly toxin-experienced cohort, significant benefits in specific and global measures of disease severity were seen in the immediate post-incobotulinumtoxinA injection period. It will be interesting to see if there are improvements in QoL with consistent individualized injections over a longer period.

Therapeutic window of lamotrigine for mood disorders: a naturalistic retrospective study.

Lamotrigine is widely used for mood disorders including bipolar disorder and major depression, but its therapeutic levels have yet to be determined. This study was conducted to investigate the hypothesis that lamotrigine may have a therapeutic window for mood disorders. 25 patients with mood disorders received lamotrigine for more than one year during which time plasma lamotrigine levels were measured at least once. Their mental state was retrospectively and regularly but blindly assessed using the Clinical Global Impression-Severity (CGI-S) scale. In order to investigate our hypothesis, we depicted the relationship between the last lamotrigine levels and the last CGI scores in 25 patients. If any, the potential therapeutic window was further investigated. The relationship between the last lamotrigine levels and the last CGI scores in the 25 patients indicated the presence of a therapeutic window of lamotrigine from 5 to 11 μg/mL. The repeated measures of ANOVA reached a significant tendency of the effects of lamotrigine levels within 5-11 μg/mL on better CGI-S scores, and the CGI-S scores at the last observation of the 15 patients whose lamotrigine levels were within 5-11 μg/mL were significantly better than those of 10 patients whose lamotrigine levels were not within 5-11 μg/mL. These findings suggest that lamotrigine may have a therapeutic window for patients with mood disorder from 5 to 11 μg/mL.

The Selective Neurokinin 3 Antagonist AZD2624 Does Not Improve Symptoms or Cognition in Schizophrenia

Problems with the efficacy of second-generation antipsychotics on negative symptoms and cognition have highlighted the need for further development of drugs targeting central nervous system neurotransmitter systems other than dopamine. One target in development is neurokinin 3 (NK(3)) tachykinin receptors, which are coreleased and interact with dopamine. This study investigates the efficacy, tolerability, and cognitive effects of AZD2624, a selective, orally active NK(3) receptor antagonist, in symptomatic patients with schizophrenia. Patients were randomly assigned to 1 of 3 treatment groups: AZD2624 40 mg, placebo, or olanzapine 15 mg. Treatment lasted for 28 days, and the Positive and Negative Syndrome Scale, the Clinical Global Impression Severity Scale and Improvement Scales, and cognition as assessed by CogState were used as primary outcome measures. There were no significant differences in patients treated with AZD2624 versus placebo on change in Positive and Negative Syndrome Scale total score and Clinical Global Impression Severity Scale; in addition, no change in CogState measures was found. Results of the trial do not support a role for the NK(3) antagonist AZD2624 as a therapeutic treatment for acute schizophrenia when used as monotherapy.

A phase II/III trial of bitopertin monotherapy compared with placebo in patients with an acute exacerbation of schizophrenia – Results from the CandleLyte study

Bitopertin is a glycine reuptake inhibitor postulated to improve N-methyl-d-aspartate receptor hypofunction by increasing synaptic glycine concentrations. This randomised, double-blind, placebo- and active-controlled phase II/III trial evaluated the efficacy and safety of bitopertin monotherapy over 4 weeks in patients with acute exacerbation of schizophrenia. Of 301 patients randomised, 299 received placebo (n=80), bitopertin 10mg (n=80) or 30mg (n=77), or olanzapine 15mg (n=62). The primary endpoint, change from baseline in mean Positive and Negative Syndrome Scale (PANSS) total score, showed non-statistically significant improvements with bitopertin 30mg and olanzapine vs. placebo: bitopertin 10mg (–11.7; standard error [SE], 1.89; p=0.945), bitopertin 30mg (–15.3; SE, 1.87; p=0.211), olanzapine (–14.9; SE, 2.13; p=0.295) and placebo (–11.9; SE, 1.90). The PANSS positive subscale score, a secondary endpoint, also showed improvement with bitopertin 30mg (p=0.030) whereas a trend was observed with olanzapine (p=0.072) vs. placebo. Although not statistically significant, bitopertin 30mg and olanzapine reduced overall illness severity (Clinical Global Impression–Severity Scale; p=0.098 and p=0.126, respectively). More patients receiving bitopertin 30mg (51.3%) or olanzapine (52.5%) than placebo (32.9%) were ready for hospital discharge at Week 4 (bitopertin, p=0.014; olanzapine, p=0.024). In summary, this study failed due to lack of statistical separation of either bitopertin or olanzapine (active control) from placebo on the primary endpoint. Of interest, improved positive symptoms and readiness for hospital discharge were associated with both bitopertin and olanzapine treatment. Bitopertin was safe and well tolerated in this study.

Reliability and validity of the Thai version of the Yale&amp;ndash;Brown Obsessive Compulsive Scale &amp;ndash; Second Edition in clinical samples

PurposeThe Yale–Brown Obsessive Compulsive Scale (Y-BOCS) is regarded as the most acceptable tool for measuring obsessive–compulsive disorder symptom severity. Recently, the Yale–Brown Obsessive Compulsive Scale – Second Edition (Y-BOCS-II) was developed for better measurement. The study reported here aimed to evaluate the psychometric properties of the Thai version of the Yale–Brown Obsessive Compulsive Scale – Second Edition (Y-BOCS-II-T).Patients and methodsThe original version of the Y-BOCS-II was translated into Thai, which involved forward translation, synthesis of the translation, and back translation. Modification and cross-cultural adaptation were completed accordingly. The developed Y-BOCS-II-T, together with the Hamilton Rating Scale for Depression, was administered to 41 patients who had a primary diagnosis of obsessive–compulsive disorder. The patients then completed the Pictorial Thai Quality of Life instrument and Patient Health Questionnaire. Lastly, the Global Assessment of Functioning (GAF) and the Clinical Global Impression – Severity Scale (CGI-S) of all patients were blindly rated by another experienced psychiatrist who was not the interviewer.ResultsThe mean total score of the Yale–Brown Obsessive Compulsive Scale – Second Edition – Severity Scale (Y-BOCS-II-SS) and the Yale–Brown Obsessive Compulsive Scale – Second Edition – Symptom Checklist (Y-BOCS-II-SC) were 18.44 (standard deviation =10.51) and 15.85 (standard deviation =9.58), respectively. The Y-BOCS-II-T had satisfactory internal consistency (Cronbach’s alpha =0.94 for the Severity Scale, and Kuder–Richardson Formula 20 =0.90 for the Symptom Checklist). Inter-rater reliability was excellent for both the Y-BOCS-II-SS and Y-BOCS-II-SC. Factor analysis of Y-BOCS-II-SS items revealed a two-factor component associated with obsession and compulsion. The Y-BOCS-II-SS correlated highly with the CGI-S and GAF (r =0.75 and −0.76, respectively), but the Y-BOCS-II-SC correlated moderately (r=0.42 for CGI-S; r=−0.39 for GAF). The Y-BOCS-II-SS and Y-BOCS-II-SC slightly to moderately correlated with the Hamilton Rating Scale for Depression, Patient Health Questionnaire, and Pictorial Thai Quality of Life, which might indicate the comorbidity depression and its effect on quality of life.ConclusionThe Y-BOCS-II-T is a psychometrically reliable and valid measure for the assessment of both severity and characteristics of obsessive–compulsive symptoms in Thai clinical samples.

The advantage of using 3-week data to predict response to aripiprazole at week 6 in first-episode psychosis

We investigated the efficacy and safety of aripiprazole in first-episode psychosis and explored the association between early response and later response to this medication. This was a 6-week, open-label, multicenter trial. The study population consisted of 59 patients with a DSM-IV diagnosis of a schizophreniform disorder, schizoaffective disorder, schizophrenia, or psychotic disorder not otherwise specified. The primary outcome measures were the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression-Severity scale. To assess the safety, we measured the drug-related adverse events, weight, and lipid-related variables. The sensitivity, specificity, positive predictive value, and negative predictive value were calculated for the response status at weeks 2 and 3 to predict the subsequent response at week 6. Among the 59 participants, 38 were able to complete the 6-week trial. Treatment with aripiprazole resulted in significant improvement in the PANSS and Clinical Global Impression scores over time. The response rate (defined as a ≥30% decrease in the PANSS total score from baseline to the last observation) was 69.1%. The most accurate prediction of later response in terms of negative predictive value and specificity was a reduction in the PANSS total score from baseline to week 3 of at least 20%. Aripiprazole had a modest side effect burden and was characterized by a safe profile with respect to weight and metabolic side effects. These results indicate that aripiprazole is effective and safe in the treatment of first-episode psychosis. The response at week 3, rather than week 2, predicted the later response more accurately.

Evaluación psicométrica y desarrollo de una versión reducida de la nueva escala de ansiedad en una muestra hospitalaria de Lima, Perú

To assess psychometric properties and to develop a shorter version of a new anxiety scale. The 130-item new anxiety scale (NAS-130) was administered to 254 psychiatric outpatients of a general hospital in Lima, Peru. A categorical principal component analysis (CATPCA) was performed with the 130 items and based on these results and the relation of each item with a Clinical Global Impressions Severity Scale for anxiety (CGI-S) the scale was simplified. In addition, the CGI-S was used to assess the concurrent validity of the scale. The NAS-130 had a Cronbach's alpha of 0.97 and a Spearman correlation coefficient (Rho) with CGI-S of 0.44 (p<0.01). After item selection, a 72-item scale was obtained (NAS-72) which had a Cronbach's alpha of 0.96 and a Rho with CGI-S of 0.47 (p<0.01). All items of NAS-72 had saturation coefficients greater than 0.4 in one dimension according to the CATPCA. NAS-130 and NAS-72 scores were significantly higher in women than in men (p<0.01). The NAS-72 has psychometric characteristics that suggest that it could be useful to measure anxiety in our population; however, the scores should be interpreted differently in men and women.

Impact of Once- Versus Twice-Daily Perphenazine Dosing on Clinical Outcomes

The objective of this study was to evaluate the impact of once- versus twice-daily dosing of perphenazine, which has a plasma half-life of 8-12 hours, on clinical outcomes in patients with schizophrenia. Data from phase 1 of the Clinical Antipsychotic Trial of Intervention Effectiveness (CATIE) conducted between January 2001 and December 2004 were used in this post hoc analysis. Patients with schizophrenia (DSM-IV) randomly allocated to treatment with perphenazine were also randomly assigned to once-daily (N = 133) or twice-daily (N = 124) dosing and followed over 18 months. Discontinuation rate and time to discontinuation were used as primary outcomes to compare the 2 groups. The following clinical outcomes were analyzed as secondary measures: efficacy-Positive and Negative Syndrome Scale, Clinical Global Impressions-Severity scale, Calgary Depression Scale for Schizophrenia, and Drug Attitude Inventory and safety/tolerability-Abnormal Involuntary Movement Scale, Barnes Akathisia Rating Scale, Simpson-Angus Scale, and body weight. Data on treatment-emergent adverse events, concomitant psychotropic medications, and medication adherence (pill count and clinician rating scale) were also analyzed for each group. No significant differences were found in any outcome measures between the once-daily and twice-daily dosing groups, which remained the same when using the mean dose of perphenazine as a covariate. Perphenazine is routinely administered in a divided dosage regimen because of its relatively short plasma half-life. However, the present findings challenge such a strategy, suggesting that once-daily represents a viable treatment option. Results are discussed in the context of more recent evidence that challenges the need for high and continuous dopamine D2 receptor blockade to sustain antipsychotic response. ClinicalTrials.gov identifier: NCT00014001.

Cognitive functioning and insight in schizophrenia and in schizoaffective disorder.

The aim of this study was to investigate cognitive functioning and insight of illness in two groups of patients during their stable phases, one with schizophrenia and one with schizoaffective disorder. We recruited 104 consecutive outpatients, 64 with schizophrenia, 40 with schizoaffective disorder, in the period between July 2010 and July 2011. They all fulfilled formal Diagnostic and Statistical Manual of Mental disorders (DSM-IV-TR) diagnostic criteria for schizophrenia and schizoaffective disorder. Psychiatric assessment included the Clinical Global Impression Scale-Severity (CGI-S), the Positive and Negative Sindrome Scale (PANSS), the Calgary Depression Scale for Schizophrenia (CDSS) and the Global Assessment of Functioning (GAF). Insight of illness was evaluated using SUMD. Neuropsychological assessment included Winsconsin Card Sorting Test (WCST), California Verbal Learning Test (CVLT), Stroop Test and Trail Making Test (TMT). Differences between the groups were tested using Chi-square test for categorical variables and one-way analysis of variance (ANOVA) for continuous variables. All variables significantly different between the two groups of subjects were subsequently analysed using a logistic regression with a backward stepwise procedure using diagnosis (schizophrenia/schizoaffective disorder) as dependent variable. After backward selection of variables, four variables predicted a schizoaffective disorder diagnosis: marital status, a higher number of admission, better attentive functions and awareness of specific signs or symptoms of disease. The prediction model accounted for 55% of the variance of schizoaffective disorder diagnosis. With replication, our findings would allow higher diagnostic accuracy and have an impact on clinical decision making, in light of an amelioration of vocational functioning.

Rapid response to methylphenidate as an add-on therapy to mirtazapine in the treatment of major depressive disorder in terminally ill cancer patients: A four-week, randomized, double-blinded, placebo-controlled study

This is a 4 week, randomized, double-blind, placebo-controlled study to examine the effects of methylphenidate as add-on therapy to mirtazapine compared to placebo for treatment of depression in terminally ill cancer patients. It involved 88 terminally ill cancer patients from University of Malaya Medical Centre, Kuala Lumpur, Malaysia. They were randomized and treated with either methylphenidate or placebo as add on to mirtazapine. The change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 3 was analyzed by linear regression. Changes of MADRS and Clinical Global Impression-Severity Scale (CGI-S) over 28 days were analyzed using mixed model repeated measures (MMRM). Secondary analysis of MADRS response rates, defined as 50% or more reduction from baseline score. A significantly larger reduction of Montgomery-Åsberg Depression Rating Scale (MADRS) score in the methylphenidate group was observed from day 3 (B=4.14; 95% CI=1.83–6.45). Response rate (defined as 50% or more reduction from baseline MADRS score) in the methylphenidate treated group was superior from day 14. Improvement in Clinical Global Impression-Severity Scale (CGI-S) was greater in the methylphenidate treated group from day 3 until day 28. The drop-out rates were 52.3% in the methylphenidate group and 59.1% in the placebo group (relative risk=0.86, 95%CI=0.54–1.37) due to cancer progression. Nervous system adverse events were more common in methylphenidate treated subjects (20.5% vs 9.1%, p=0.13). In conclusions, methylphenidate as add on therapy to mirtazapine demonstrated an earlier antidepressant response in terminally ill cancer patients, although at an increased risk of the nervous system side effects.

Pharmacological treatment strategies in obsessive compulsive disorder: A cross-sectional view in nine international OCD centers

It is unknown what next-step strategies are being used in clinical practice for patients with obsessive-compulsive disorder (OCD) who do not respond to first-line treatment. As part of a cross-sectional study of OCD, treatment and symptom information was collected. Consecutive OCD out-patients in nine international centers were evaluated by self-report measures and clinical/structured interviews. OCD symptom severity was evaluated by the Yale Brown Obsessive Compulsive Scale (YBOCS) and Clinical Global Impression-Severity Scale (CGI-S). Clinical response to current treatment was evaluated by the CGI-Improvement Scale (CGI-I ≤ 2). In total, 361 participants reported taking medication; 77.6% were taking a selective serotonin reuptake inhibitor; 50% reported use of at least one augmentation strategy. Antipsychotics were most often prescribed as augmenters (30.3%), followed by benzodiazepines (24.9%) and antidepressants (21.9%). No differences in OCD symptom severity were found between patients taking different classes of augmentation agents. Results from this international cross-sectional study indicate that current OCD treatment is in line with evidence-based treatment guidelines. Although augmentation strategies are widely used, no significant differences in OCD symptom severity were found between monotherapy and augmentation or between different therapeutic agents.

A Comparative Study between Olanzapine and Risperidone in the Management of Schizophrenia.

Introduction. Since a variety of comparisons between risperidone and olanzapine have resulted in diverse outcomes, so safety and efficacy of them were compared again in a new trial. Method. Sixty female schizophrenic patients entered into one of the assigned groups for random allocation to olanzapine or risperidone (n = 30 in each group) in a double-blind, 12-week clinical trial. Scale for Assessment of Positive Symptoms (SAPS) and Scale for Assessment of Negative Symptoms (SANS) were used as the primary outcome measures. Clinical Global Impressions-Severity Scale (CGI-S), Schedule for Assessment of Insight (SAI), and finally Simpson Angus Scale (SAS) as well were employed as secondary scales. Results. While both of olanzapine and risperidone were significantly effective for improvement of positive symptoms (P < 0.0001), as regards negative symptoms, it was so only by means of olanzapine (P < 0.0003). CGI-S and SAI, as well, were significantly improved in both of the groups. SAS increment was significant only in the risperidone group (P < 0.02). Conclusion. While both of olanzapine and risperidone were equally effective for improvement of positive symptoms and insight, olanzapine showed superior efficacy with respect to negative symptoms, along with lesser extrapyramidal side effects, in comparison with risperidone.

EPA-1550 - Paliperidone palmitate in acute patients with schizophrenia: treatment response, safety and tolerability ? a prospective flexible-dose study in patients previously unsuccessfully treated with oral antipsychotics

Introduction This study explores tolerability, safety and treatment response of flexible doses of the atypical long-acting antipsychotic paliperidone palmitate (PP) in adult patients with an acute exacerbation of schizophrenia previously unsuccessfully treated with oral antipsychotics. Methods International prospective open-label 6-month study. Outcome parameters were change in Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression-Severity Scale (CGI-S), treatment-emergent adverse events (TEAEs) and weight change. Results 212 acute patients, 59.0% male, mean age 36.4 ±12.1 years, 85.4% paranoid schizophrenia were enrolled. 70.3% of patients completed the study. Most frequent reasons for early discontinuation were subject choice (9.4%), or an adverse event (9.0%). Recommended initiation regimen of PP (150 mg eq on day 1 and 100 mg eq on day 8) was administered in 92.9% of subjects. Mean baseline PANSS total score decreased from 98.5±20.1 as of day 8 of treatment to 67.4±24.0 at endpoint (mean change -31.0±28.97; 95% confidence interval [CI]-35.0;-27.1; p Conclusions These data support results from previous randomized controlled studies that flexibly dosed paliperidone palmitate is well tolerated and associated with an early and clinically relevant treatment response in acute schizophrenia patients previously unsuccessfully treated with oral antipsychotics.

The effectiveness of cross-tapering switching to ziprasidone in patients with schizophrenia or schizoaffective disorder.

ObjectiveSwitching antipsychotics is one useful therapeutic option when the treatment of schizophrenia encounters suboptimal efficacy and intolerability issues. This study aimed to investigate the efficacy and tolerability of cross-tapering switching to ziprasidone from other antipsychotics.MethodsA total of 67 patients with schizophrenia or schizoaffective disorder were recruited in this 12-week, multicenter, non-comparative, open-label trial. Prior antipsychotics were allowed to be maintained for up to 4 weeks during the titration of ziprasidone. Efficacy was primarily measured using the 18-item Brief Psychotic Rating Scale (BPRS) at baseline, 4 weeks, 8 weeks, and 12 weeks. Efficacy was secondarily measured by the Clinical Global Impression-Severity (CGI-S) scale and the Global Assessment of Functioning (GAF) scale at each visit. Regarding the metabolic effects of switching to ziprasidone, weight, body mass index (BMI), waist-to-hip ratio (WHR), and lipid profile-including triglyceride (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total cholesterol levels-were measured at each follow-up visit.ResultsThe BPRS scores were significantly improved at 12 weeks after switching to ziprasidone (F=5.96, df=2.11, p=0.003), whereas the CGI-S and GAF scores were not significantly changed. BMIs, WHRs, and TG levels were significantly decreased, with no significant changes in other lipid profiles.ConclusionCross-tapering switching to ziprasidone is effective for patients with schizophrenia spectrum disorders. Beyond the efficacy of the procedure, favorable metabolic profiles show that switching to ziprasidone may be helpful for maintenance therapy over an extended period.

A follow-up on patients with severe mental disorders in Sardinia after two changes in regional policies: poor resources still correlate with poor outcomes

BackgroundThis survey followed a cohort of patients with chronic psychosis recruited from five catchment areas (DSMs) of the Sardinian community mental health services. The objective was to examine whether the amount of resources in the different sites may be a determinant of the outcomes.MethodsNaturalistic follow-up study on 309 consecutive users with diagnosis of schizophrenic disorder, schizoaffective disorder, bipolar affective disorder with psychotic symptoms (DSM-IV TR) of five Sardinian community mental health services. Mental state and clinical symptoms along with functioning were assessed using semi-structured clinical interviews (ANTAS), Clinical Global Impression Severity Scale (CGI-S), Global Assessment of Functioning Scale (GAF) and Health of the Nation Outcome Scales (HONOS). Assessments were conducted at the beginning of the study and after one year.ResultsThe proportion of professionals working in all DSMs participating in the study was found lower than the national Italian standard (0.7 vs 1.0 per 1,500 inhabitants). Follow-up revealed significant differences between DSMs in the improvement of the Honos scores (F = 5.932, p = 0.000). These differences correlate with the improvement of resources in terms of number of professionals during, and one year prior, to the trial.ConclusionsThe study shows that mental health services provided in the public sector in Sardinia are still very resource-poor, at least in terms of human resources. Our findings suggest that mental health service resources influence outcomes as regards the social functioning of users. We urge policy makers to take these observations into account when planning future services.

Persistence and resolution of suicidal ideation during treatment of depression in patients with significant suicidality at the beginning of treatment: The CRESCEND study

BackgroundThe appropriate length of time for patients who visit clinics with significant suicidal ideation to be closely monitored is a critical issue for clinicians. We evaluated the course of suicidal ideation and associated factors for persistent suicidality in patients who entered treatment for depression with significant suicidal ideation. MethodsA total of 565 patients who had both moderate to severe depression (Hamilton Depression Rating Scale (HAMD) score ≥14) and significant suicidal ideation (Beck Scale for Suicide Ideation (SSI-B) score ≥6) were recruited from 18 hospitals in South Korea. Participants were assessed using the SSI-B, HAMD, Hamilton Anxiety Rating Scale, and Clinical Global Impression Scale-severity during a 12-week naturalistic treatment with antidepressant intervention. Participants were classified into resolved suicidality or persistent suicidality groups according to whether their suicidal ideation improved to SSI-B scores <6 and were sustained for 12 weeks. ResultsDuring the 12-week treatment, 206 (36.4%) patients were classified in the resolved suicidality group. Persistent suicidality was associated with intervention with SSRIs, higher SSI-B baseline score, and no HAMD or HAMA remission. The proportions of participants who had persistent suicidal ideation even with HAMD remission or response were 0.25 and 0.34, respectively. LimitationsThis study was observational, and the treatment modality was naturalistic. ConclusionsA considerable number of patients had persistent suicidal ideation despite 12 weeks of antidepressant treatment. Close monitoring for suicidal ideation may be needed beyond the initial weeks of treatment and even after a response to antidepressants is observed.