Sheehan Disability Scale Research Articles

A study on assessment of disability associated with common mental disorders in the slum population of Indore

Background: Changing life styles have increase chance of common mental disorders (CMD) which may lead to disability. Aims and Objectives: The aim of the study was (1) to assess CMD in urban slum community and (2) to gain attention of policy makers toward the mental health and its need of the community to address unmet care. Materials and Methods: A crosssectional study was conducted in which 423 people were screened with the help of a pretestedquestionnaire by Self Reporting Questionnaire (SRQ-20). All the subjects who scored 7 and more in SRQ-20 were further evaluated using Sheehan disability scale. Results: Out of 423 subject, 76.12% reported typical response within 7 in SRQ-20 scoring. Common mental disorder was found in 16.07% with SRQ-20 scoring between 7 and 13. Severe distress was found in 7.80% of the population with SRQ-20 score >14. Among psychological distress group, females scored higher with 10.63%. In the severe distress group, again females scored higher with 4.96%, although this was not statistically significant. A total of 101 subjects were found to have CMD after screening the population and its prevalence come to 238.77 per thousand. Mild disability was found in 59.41% of the people with CMD and 34.65% moderate disability and 5.94% reported severely disability, which was not statistically significant. Conclusion: On the basis of our study findings, we conclude that their mental health requires attention, which is an essential part of an individual’s health. It is essential to design intervention that aim at allaying their distress which can improve their mental health, however, being of a descriptive nature and the study population coming from only one slum the above mentioned finding cannot be generalized.

The NVP QOL Questionnaire: Psychometric properties of the self-report measure of health-related quality of life for nausea and vomiting during pregnancy.

The Nausea and Vomiting of Pregnancy Quality of Life (NVP QOL) Questionnaire is a self-report measure of health-related QOL for nausea and vomiting during pregnancy. This study determines the best fitting factor structure for the NVP QOL Questionnaire and explores its measurement invariance in terms of observation time and parity. A test-retest study of pregnant women was conducted at Gestational Weeks (GWs) 10-13 (T1: N = 381) and 1 week later (T2: n = 128) at one hospital and five clinics with the NVP QOL and the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE). Exploratory and confirmatory factor analyses were performed to compare different factor structure models and evaluate measurement invariance of the best fitting model between two time points and between primiparas and multiparas. Concurrent validity of the NVP QOL was clarified by correlations with the PUQE, Sheehan Disability Scale, and other scales. The one-factor model had the best fit. This factor structure model was acceptable up to the factor invariance level for two time points and up to the factor mean level for primiparas versus multiparas. Correlations between NVP QOL, PUQE, and Sheehan Disability Scale scores were strong. Women with higher NVP QOL scores were more likely to lose weight, have lower daily fluid intake, have reduced fluid and food intake since pregnancy began, and receive outpatient or inpatient treatment. The one-factor structure and measurement invariance of the NVP QOL at different times and parities were demonstrated, suggesting that the NVP QOL can be used to evaluate primiparas and multiparas in a longitudinal study.

Change in serum urate level with urate-lowering therapy initiation associates in the immediate term with patient-reported outcomes in people with gout

ObjectiveTo examine the associations of changes in serum urate (SU) with health-related quality of life (HRQOL) in gout. MethodsWe used the first 6-months of data from four interventional trials and one observational, open-label study of urate-lowering therapy (ULT) use. HRQOL were assessed at baseline and every 3-months, and SU was measured monthly. Primary outcome measures were Short-form 36 physical and mental component summary scores, Health Assessment Questionnaire Disability Index (HAQ-DI), Sheehan Disability Scale (SDS), Patient Global Assessment, and pain scores in the last week. Linear mixed models for each outcome were adjusted as appropriate for current SU, change in urate in the last month, number of flare-affected days in the last month, baseline BMI, age, comorbidities, sex, ethnicity, trial/study and treatment combination, and tophi status (fixed effects); subject, and the trial/study month were random effects. ResultsHigher current SU correlated with reduced physical and mental HRQOL, and increased SDS and pain but not with HAQ-DI score. In the first 6-months of new/escalating ULT use, absolute change in SU levels associated with poorer outcomes on the HAQ-DI scale (β (95% CI) = 0.013 (0.007–0.019)) and poorer outcomes on SDS, SF-36 MCS, patient global and pain scales. Reduction of SU associated with poorer outcomes in all six measures. ConclusionHigh SU levels were associated with poorer HRQOL, pain and Sheehan disability score. Recent SU level fluctuations are associated with poorer outcomes, primarily driven by a reduction in SU. Clinical emphasis on slow rather than fast SU reduction and the routine use of effective, anti-inflammatory medications at ULT initiation/escalation may avoid short-term poor outcomes.

Mitochondrial modulators for obsessive–compulsive and related disorders: a systematic review and meta-analysis

It remains unclear whether mitochondrial modulators (MMs) are beneficial in the treatment of obsessive–compulsive and related disorders. Thus, in an attempt to answer this clinical question, we performed a systematic review and a random-effects meta-analysis of double-blind, randomized, placebo-controlled trials. The primary outcome was change in overall symptoms as measured using standardized rating scales. Other outcomes were response to treatment; improvement in anxiety-related scales scores, depression-related scale scores, Clinical Global Impression Severity Scale (CGI-S) scores, and Sheehan Disability Scale (SDS) scores; all-cause discontinuation; and individual adverse events. We calculated the standardized mean differences for continuous outcomes and risk ratios for dichotomous outcomes with 95% confidence intervals. We reviewed 17 studies (n = 629, 72.62% female; duration = 2–20 weeks; mean age = 30.47 years) of MMs: eicosapentaenoic acid (K = 1), folic acid (K = 1), lithium (K = 1), N-acetylcysteine (K = 10), inositol (K = 3), and silymarin (K = 1). MMs outperformed placebo in overall improvement in symptoms (p < 0.01) and in improving anxiety-related scale scores (p = 0.05). Subgroup analysis of individual MMs revealed that although overall symptoms were better improved by N-acetylcysteine (p < 0.01) and lithium (p = 0.04), no MMs outperformed placebo in terms of improving anxiety-related scale scores. Neither pooled nor individual MMs outperformed placebo in improving response to treatment, depression-related scale scores, CGI-S scores, SDS scores, or all-cause discontinuation. N-acetylcysteine was no more associated with a higher incidence of individual adverse events including gastrointestinal symptoms, than placebo. In conclusion, N-acetylcysteine was beneficial in the treatment of obsessive–compulsive and related disorders. However, further study with larger samples is necessary to confirm this finding.

French adaptation and validation of the Panic Disorder Severity Scale—self-report

BackgroundThe aims of this study were to conduct a cross-cultural validation of the Panic Disorder Severity Scale – Self-Report (PDSS-SR) and to examine psychometric properties of the French-Canadian version.MethodsA sample of 256 adults were included in the validation study based on data from the baseline interview of a clinical trial on transdiagnostic cognitive-behavioral therapy for mixed anxiety disorders. Participants completed the Anxiety and Related Disorders Interview Schedule (ADIS-5), and self-report instruments including the PDSS-SR, Beck Anxiety Inventory (BAI), Mobility Inventory for Agoraphobia (MIA), Sheehan Disability Scale (SDS), Patient Health Questionnaire (PHQ-9), Social Phobia Inventory (SPIN), Insomnia Severity Index (ISI) and Penn State Worry Questionnaire (PSWQ). The cross-cultural adaptation in French of the PDSS-SR included a rigorous back-translation process, with an expert committee review. Sensitivity to change was also examined with a subgroup of patients (n = 72) enrolled in the trial.ResultsThe French version of the PDSS-SR demonstrated good psychometric properties. The exploratory factor analysis supported a one factor structure with an eigenvalue > 1 that explained 64.9% of the total variability. The confirmatory factor analysis (CFA) corroborated a one-factor model with a good model fit. Internal consistency analysis showed a .91 Cronbach’s alpha. The convergent validity was adequate with the ADIS-5 clinical severity ratings for panic disorder (r = .56) and agoraphobia (r = .39), as well as for self-report instruments [BAI (r = .63), MIA (accompanied: r = .50; alone: r = .47) and SDS (r = .37)]. With respect to discriminant validity, lower correlations were found with the SPIN (r = .17), PSWQ (r = .11), ISI (r = .19) and PHQ-9 (r = .28). The optimal threshold for probable diagnosis was 9 for the PDSS-SR and 4 for the very brief 2-item version. The French version showed good sensitivity to change.ConclusionsThe French version of the PDSS-SR has psychometric properties consistent with the original version and constitutes a valid brief scale to assess the severity of panic disorder and change in severity over time, both in research and clinical practice.

Clinical and Financial Outcomes Associated With a Workplace Mental Health Program Before and During the COVID-19 Pandemic

Investment in workplace wellness programs is increasing despite concerns about lack of clinical benefit and return on investment (ROI). In contrast, outcomes from workplace mental health programs, which treat mental health difficulties more directly, remain mostly unknown. To determine whether participation in an employer-sponsored mental health benefit was associated with improvements in depression and anxiety, workplace productivity, and ROI as well as to examine factors associated with clinical improvement. This cohort study included participants in a US workplace mental health program implemented by 66 employers across 40 states from January 1, 2018, to January 1, 2021. Participants were employees who enrolled in the mental health benefit program and had at least moderate anxiety or depression, at least 1 appointment, and at least 2 outcome assessments. A digital platform that screened individuals for common mental health conditions and provided access to self-guided digital content, care navigation, and video and in-person psychotherapy and/or medication management. Primary outcomes were the Patient Health Questionnaire-9 for depression (range, 0-27) score and the Generalized Anxiety Disorder 7-item scale (range, 0-21) score. The ROI was calculated by comparing the cost of treatment to salary costs for time out of the workplace due to mental health symptoms, measured with the Sheehan Disability Scale. Data were collected through 6 months of follow-up and analyzed using mixed-effects regression. A total of 1132 participants (520 of 724 who reported gender [71.8%] were female; mean [SD] age, 32.9 [8.8] years) were included. Participants reported improvements from pretreatment to posttreatment in depression (b = -6.34; 95% CI, -6.76 to -5.91; Cohen d = -1.11; 95% CI, -1.18 to -1.03) and anxiety (b = -6.28; 95% CI, -6.77 to -5.91; Cohen d = -1.21; 95% CI, -1.30 to -1.13). Symptom change per log-day of treatment was similar post-COVID-19 vs pre-COVID-19 for depression (b = 0.14; 95% CI, -0.10 to 0.38) and anxiety (b = 0.08; 95% CI, -0.22 to 0.38). Workplace salary savings at 6 months at the federal median wage was US $3440 (95% CI, $2730-$4151) with positive ROI across all wage groups. Results of this cohort study suggest that an employer-sponsored workplace mental health program was associated with large clinical effect sizes for employees and positive financial ROI for employers.

Quality of Life And Disability of Patients With Bipolar Disorder According To Treatment Response

Bipolar Disorder (BD) is a lifelong, chronic mental illness with recurrent depressive, manic, hypomanic, or mixed episodes, with euthymic periods between episodes. The inadequate response is defined as the ineffectiveness of the drug from two different groups, despite being used sufficient dose and duration for the specific attack of the disease. BD is also related to impairment in functionality and disability. Most studies have demonstrated marked deterioration of quality of life and disability in patients with BD, even if they are clinically considered euthymic. Our study aims to determine the factors affecting the response to treatment and compare the quality of life and disability in patients with bipolar disorder. Our study included 150 patients with BD between 18-65 years who applied to the Dicle University Faculty of Medicine Psychiatry Clinic. Patients were divided into two groups according to treatment response. Sociodemographic Data Form, Clinical Global Impression Scale (CGI), Sheehan Disability Scale (SDS), World Health Organization Quality of Life Scale (WHOQOL-27) were applied to the participants. Inadequate response group had higher mood episodes, number of hospitalization, inadequate family support, non-adherence to treatment, suicide attempt, psychiatric comorbidity, late-onset treatment, and higher mean CGI-S and SDS subscales scores and lower mean WHOQOL-BREF 27 score. Inadequate response to treatment was associated with worse functionality and disability. Inadequate response related factors such as misdiagnosis, late diagnosis, late treatment, low adherence to treatment, missed psychiatric comorbidity, and inadequate family support should be minimized. Treatment should aim not only to remission symptoms but also aim complete functional recovery and no disability in work, social life, and family life/home responsibilities.

Study design of VGOAL-J: an observational, prospective cohort study to assess effectiveness of vortioxetine on goal achievement and work productivity in patients with MDD in Japan

IntroductionGoal attainment scaling (GAS) is a method to assess the patient experience of whether a treatment is successful and capture outcomes across a diverse range of goal areas. However, this approach has not yet been used in assessing the treatment of Major Depressive Disorder (MDD) in Japan. GAS was first developed by Kiresuk and Sherman in the 1968, it is increasingly recognised as a sensitive method for recording patient-centred outcomes throughout the course of treatment.ObjectivesTo demonstrate the effectiveness of vortioxetine on patient’s goal achievement and depressive symptoms, emotional, cognitive, overall function and quality of life.MethodsVGOAL-J is a prospective, multi-center, observational cohort study of outpatients initiating vortioxetine treatment for MDD in Japan. Patients with a diagnosis of MDD according to DSM-5 who are 18 to 65 years will be enrolled from 20 sites in Japan and followed for 24 weeks. A total number of 120 patients is planned for enrolment. Primary outcome measures are GAS-D, WPAI, secondary outcome measures include Montgomery – Åsberg Depression Rating Scale (MADRS), Sheehan Disability Scale (SDS), Perceived Deficits Questionnaire-Depression 5-item (PDQ-D-5), Oxford Depression Questionnaire (ODQ), EuroQol-5 Dimension (EQ-5D). Safety will be also assessed with Adverse Events collected during the study.ResultsThe results will be disseminated in late 2022 and provide new insights on GAS-D as an effective strategy to assess MDD treatment in Japan.ConclusionsWe expect to observe patients treated with vortioxetine achieving their treatment goals as assessed by GAS-D and improvements on patient- and clinician-reported measures in real-world settings.DisclosureProf. K. Watanabe reports consultancies undertaken for Eli Lilly, Otsuka Pharmaceutical, Sumitomo Dainippon Pharma, Taisho Toyama Pharmaceutical, and Takeda Pharmaceutical, honoraria received from Daiichi Sankyo, Eisai, Eli Lilly, GlaxoSmithKline, J

Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder

Objective: Altered glutamatergic neurotransmission has been implicated in the pathogenesis of depression. This trial evaluated the efficacy and safety of AXS-05 (dextromethorphan-bupropion), an oral N-methyl-D-aspartate (NMDA) receptor antagonist and σ1 receptor agonist, in the treatment of major depressive disorder (MDD).Methods: This double-blind, phase 3 trial, was conducted between June 2019 and December 2019. Patients with a DSM-5 diagnosis of MDD were randomized in a 1:1 ratio to receive dextromethorphan-bupropion (45 mg-105 mg tablet) or placebo, orally (once daily for days 1-3, twice daily thereafter) for 6 weeks. The primary endpoint was the change from baseline to week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. Other efficacy endpoints and variables included MADRS changes from baseline at week 1 and 2, clinical remission (MADRS score ≤ 10), clinical response (≥ 50% reduction in MADRS score from baseline), clinician- and patient-rated global assessments, Quick Inventory of Depressive Symptomatology-Self-Rated, Sheehan Disability Scale, and quality of life measures.Results: A total of 327 patients were randomized: 163 patients to dextromethorphan-bupropion and 164 patients to placebo. Mean baseline MADRS total scores were 33.6 and 33.2 in the dextromethorphan-bupropion and placebo groups, respectively. The least-squares mean change from baseline to week 6 in MADRS total score was -15.9 points in the dextromethorphan-bupropion group and -12.0 points in the placebo group (least-squares mean difference, -3.87; 95% confidence interval [CI], -1.39 to -6.36; P = .002). Dextromethorphan-bupropion was superior to placebo for MADRS improvement at all time points including week 1 (P = .007) and week 2 (P < .001). Remission was achieved by 39.5% of patients with dextromethorphan-bupropion versus 17.3% with placebo (treatment difference, 22.2; 95% CI, 11.7 to 32.7; P < .001), and clinical response by 54.0% versus 34.0%, respectively (treatment difference, 20.0%; 95% CI, 8.4%, 31.6%; P < .001), at week 6. Results for most secondary endpoints were significantly better with dextromethorphan-bupropion than with placebo at almost all time points (eg, CGI-S least-squares mean difference at week 6, -0.48; 95% CI, -0.48 to -0.79; P = .002). The most common adverse events in the dextromethorphan-bupropion group were dizziness, nausea, headache, somnolence, and dry mouth. Dextromethorphan-bupropion was not associated with psychotomimetic effects, weight gain, or increased sexual dysfunction.Conclusions: In this phase 3 trial in patients with MDD, treatment with dextromethorphan-bupropion (AXS-05) resulted in significant improvements in depressive symptoms compared to placebo starting 1 week after treatment initiation and was generally well tolerated.Trial Registration: ClinicalTrials.gov Identifier: NCT04019704.

Comparison of the severity of depressive and anxiety symptoms, biomarkers, and childhood trauma among bipolar smokers and non-smokers, and controls

• Bipolar smokers presented a positive correlation between emotional abuse and leptin levels. • Bipolar smokers presented a positive correlation between leptin levels and severity of depression and anxiety symptoms. • Bipolar smokers presented a positive correlation between leptin levels and castelli risk indexes 1 and 2. • Bipolar smokers presented a positive correlation between emotional abuse and body mass index. • Bipolar smokers presented a positive correlation between triglycerides and body mass index. • Bipolar smokers presented a negative correlation between emotional abuse and quality of life. Bipolar smokers were more likely to develop a worse course, had more severity of depressive symptoms, as well as had experienced more childhood trauma, and had increased levels of leptin and inflammatory biomarkers To investigate whether the co-occurrence of bipolar disorder (BD) and tobacco use disorder (TUD) was associated with severity of symptoms, childhood trauma, lower quality of life, functional impairment, alterations in the leptin levels, inflammatory biomarkers, and lipid profile, Individuals investigated were BD smokers, BD never–smokers, non-BD smokers, and non-BD never-smokers. Socio-demographic and clinical data were assessed by structured questionnaire. Other assessments used were body mass index (BMI), Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Young Mania Rating Scale, Sheehan Disability Scale, Quality of Life (WHOQOL-BREF), Childhood Trauma Questionnaire and laboratory biomarkers (leptin, high-sensitivity Creactive protein, soluble tumor necrosis factor receptor 1 and 2, and lipid profile). BD smokers had significant positive correlation between leptin levels and emotional abuse, leptin and severity of depression, leptin and severity of anxiety, leptin and Castelli risk indexes 1 and 2, emotional abuse and BMI, BMI and triglycerides but a negative correlation between emotional abuse and quality of life. These findings suggest that bipolar smokers, whose leptin levels were increased, were linked to childhood trauma, greater severity of depressive and anxious symptoms and alterations in components of metabolism. Further studies are recommended to understand the role of leptin in the pathogenesis of bipolar smokers.

Exploring the relation between clinician ratings and patient-reported experience and outcomes

Abstract Background Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are increasingly recognized as important ways for patients to be more actively involved in their treatment and enhance shared decision-making. Objective The current study investigated the associations between PROMs, PREMs and various symptoms measures reported by clinicians and psychiatric patients. Method One hundred and twenty people admitted to a psychiatric hospital completed two PREMs, one PROM (the shortened version of the Manchester Short Assessment of Quality of Life scale) and Effects of Symptoms on Daily Functioning (the Sheehan Disability Scale), the Patient Clinical Global Impression and the Modified Colorado Symptom Index. Their psychiatrists rated them using the Global Assessment of Functioning scale, the Health of the Nation Outcome Scales and the Therapist Clinical Global Impression. Results There was a strong correlation between patient’s evaluation of their quality of life (PROM), experience of their care (PREM) and the overall severity of their condition and their progress. The pattern of correlation between patients’ and clinicians’ measures revealed a three-layer structure representing a continuum from inner experience to external presentation of experiences. Conclusion Together these findings help identify and emphasize various domains of subjective experiences and their relation to external ratings.

Effectiveness of Vortioxetine in Patients With Major Depressive Disorder in Real-World Clinical Practice: Results of the RELIEVE Study.

BackgroundRandomized controlled clinical trials have shown vortioxetine to be efficacious and well tolerated for the treatment of major depressive disorder (MDD). The Real-Life Effectiveness of Vortioxetine in Depression (RELIEVE) study was undertaken to demonstrate the effectiveness and safety of vortioxetine for the treatment of MDD in routine clinical practice.MethodsRELIEVE was a 24-week, observational, prospective cohort study in outpatients with MDD initiating treatment with vortioxetine at their physician's discretion in routine care settings in Canada, France, Italy, and the USA (NCT03555136). The primary study outcome was patient functioning assessed by the Sheehan Disability Scale (SDS). Secondary outcomes included depression severity [9-item Patient Health Questionnaire (PHQ-9)], cognitive symptoms [5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5)], and cognitive performance [Digit Symbol Substitution Test (DSST)]. Mixed models of repeated measures were used to assess change from baseline at week 24, adjusted for relevant confounders.ResultsA total of 737 patients were eligible for inclusion in the full analysis set. Most patients (73.7%) reported at least one comorbid medical condition, 56.0% had comorbid anxiety and 24.4% had comorbid generalized anxiety disorder. Improvement in least-squares (LS) mean SDS score from baseline to week 24 was 8.7 points. LS mean PHQ-9, PDQ-D-5 and DSST scores improved by 7.4, 4.6, and 6.2 points, respectively. Adverse events were observed in 21.2% of patients [most commonly, nausea (8.2% of patients)].ConclusionsThese results demonstrate the effectiveness and tolerability of vortioxetine for the treatment of MDD in a large and heterogeneous patient population representative of that encountered in routine clinical practice.

MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD

IntroductionEating disorders (EDs) and posttraumatic stress disorder (PTSD) are highly comorbid, yet there are no proven integrative treatment modalities for ED-PTSD. In clinical trials, MDMA-assisted therapy (MDMA-AT) has shown marked success in the treatment of PTSD and may be promising for ED-PTSD. MethodsNinety individuals with severe PTSD received treatment in a double-blind, placebo-controlled pivotal trial of MDMA-AT. In addition to the primary (Clinician-Administered PTSD Scale) and secondary (Sheehan Disability Scale) outcome measures, the Eating Attitudes Test 26 (EAT-26) was administered for pre-specified exploratory purposes at baseline and at study termination. ResultsThe study sample consisted of 58 females (placebo = 31, MDMA = 27) and 31 males (placebo = 12, MDMA = 19) (n = 89). Seven participants discontinued prior to study termination. At baseline, 13 (15%) of the 89 individuals with PTSD had total EAT-26 scores in the clinical range (≥20), and 28 (31.5%) had total EAT-26 scores in the high-risk range (≥11) despite the absence of active purging or low weight. In completers (n = 82), there was a significant reduction in total EAT-26 scores in the total group of PTSD participants following MDMA-AT versus placebo (p = .03). There were also significant reductions in total EAT-26 scores in women with high EAT-26 scores ≥11 and ≥ 20 following MDMA-AT versus placebo (p = .0012 and p = .0478, respectively). ConclusionsED psychopathology is common in individuals with PTSD even in the absence of EDs with active purging and low weight. MDMA-AT significantly reduced ED symptoms compared to therapy with placebo among participants with severe PTSD. MDMA-AT for ED-PTSD appears promising and requires further study.

Suicidality and Quality of Life in Treatment-Resistant Depression Patients in Latin America: Secondary Interim Analysis of the TRAL Study

BackgroundA large proportion of patients with major depressive disorder (MDD) have treatment-resistant depression (TRD). The TRAL study examines the impact of TRD on suicidality and health-related quality of life (HRQoL) among MDD patients in 4 Latin American countries.MethodsIn this multicenter, prospective, observational study, MDD patients were recruited from 33 sites in Mexico, Colombia, Brazil, and Argentina. Patients were assessed for TRD, defined as failure to respond to ≥2 antidepressant medications of adequate dose and duration. Other assessments included current disease status, Mini International Neuropsychiatric Interview (MINI), Columbia-Suicide Severity Rating Scale (C-SSRS), 5 Level EQ-5D (EQ-5D-5L), Patient Health Questionnaire-9 (PHQ-9), and Sheehan Disability Scale (SDS).Results1,475 MDD patients were included in the analysis (mean age, 45.6 years; 78% women), and 429 met criteria for TRD. Thoughts of suicide and suicide attempts were more common among TRD patients (38.7%) compared with non-TRD patients (24.9%; P < 0.0001), according to the current disease status questionnaire. The C-SSRS showed that lifetime suicidal behavior was significantly more common among TRD patients than non-TRD patients (13.8 vs. 10.0%; P = 0.0384). Compared with non-TRD patients, TRD patients showed significantly greater adverse impacts on QoL (EQ-5D-5L), more severe depression (PHQ-9), and greater functional impairment (SDS).ConclusionTRD patients in clinical sites from Mexico, Colombia, Brazil, and Argentina were more likely to experience suicidality and negative effects on HRQoL than non-TRD patients.

Comparison between Atomoxetine and OROS Methylphenidate as an Adjunctive to SSRIs in Attention-deficit/Hyperactivity Disorder Adults with Comorbid Partially Responsive Major Depressive Disorder: A Head-to-head, 12-week, Randomized, Rater-blinded Clinical Trial.

ObjectiveThis study aimed to compare the efficacy and safety of atomoxetine (ATX) and OROS methylphenidate (MPH) as adjunctive to selective serotonin reuptake inhibitors (SSRIs) in adults with attention-deficit hyperactivity disorder (ADHD) with comorbid partially responsive major depressive disorder (MDD).MethodsSixty Korean adults with ADHD and comorbid partially responsive MDD were recruited in a 12-week, randomized, rater-blinded, active-controlled trial and were evenly randomized to ATX or OROS MPH treatment.ResultsDepressive symptoms measured using the Hamilton Depression Rating Scale and Clinically Useful Depression Outcome Scale, and ADHD symptoms measured using the Adult ADHD Self-Report Scale, as well as the Clinical Global Impression-Severity, Clinical Global Impression-Improvement, and the Sheehan Disability Scale scores were significantly improved in both groups during the 12 weeks of treatment. The changes in all outcome measures during the 12-week treatment were not significantly different between the two groups (all p > 0.05). No serious adverse events were reported and there were no significant differences in systolic and diastolic blood pressure, pulse rate, weight, or body mass index between the ATX and MPH groups.ConclusionOur findings suggest that ATX and MPH can be used as adjunctive treatments in adults with ADHD and comorbid partially responsive MDD. The efficacy and tolerability of ATX and MPH in adults with ADHD did not differ significantly. Further studies should be conducted to draw a definitive conclusion.

Using the Child Sheehan Disability Scale to Differentiate Severity Level in Youth With Anxiety Disorders and Obsessive Compulsive Disorder.

The current study extends the psychometric support for the Child Sheehan Disability Scale (CSDS) as a measure of impairment associated with childhood anxiety disorders, including obsessive compulsive disorder. The CSDS was completed by 1,481 predominately Caucasian youth (55.4% female) ages 8 to 17 (M = 12.68, SD = 2.78) from primarily two-parent households and a parent across community, outpatient, intensive outpatient treatment, and residential settings. The results replicated and extended the previously found strong convergent validity, discriminant validity, and treatment sensitivity with a revised parent-report item in the larger sample. Moreover, the CSDS successfully differentiated between patients receiving treatment of different levels of intensity. These data were used to develop preliminary qualitative descriptors associating individual scores with a likely level of indicated treatment to enhance the clinical applicability of the CSDS. This study establishes the CSDS as one of the briefest and most rigorously evaluated measures of impairment associated with child anxiety. However, the performance of the CSDS must be examined in more representative samples before being applied to diverse populations.

The effectiveness of repeated intravenous ketamine on subjective and objective psychosocial function in patients with treatment-resistant depression and suicidal ideation

BackgroundKetamine has rapid and robust antidepressant effects in adults with treatment-resistant depression (TRD), while its effects on functional outcomes have not been sufficiently evaluated. The aim was to evaluate the efficacy of ketamine treatment on both subjective and objective functioning, and to explore whether improvements in depressive symptom and cognition mediated changes in functioning. MethodsAdults (n=111) with TRD and/or suicidality received six infusions of ketamine (0.5mg/kg, thrice-weekly). Depression symptoms were assessed with the Montgomery–Asberg Depression Rating Scale (MADRS) at baseline, day 13 and day 26. Cognitive domains, including processing speed, working memory, visual learning and verbal learning were measured with the MATRICS Consensus Cognitive Battery, and subjective and objective functioning were measured with the Sheehan Disability Scale (SDS) and the Global Assessment of Functioning (GAF) at the same time-points. ResultsSignificant improvement was observed in SDS total score (effect size [ES]=-1.563) and GAF score (ES=1.700) during the 26-day observation. Results from path analysis indicated that reductions of the total MADRS score and improvements in processing speed aggregately significantly mediated the reductions of SDS total score (total indirect effect coef=-3.993, 95%CI [-4.9, -3.2], direct effect coef=-1.374, 95%CI [-2.4, -0.4]) as well as the increases of GAF score (total indirect effect coef=6.022, 95%CI [4.5, 7.8], direct effect coef=3.987, 95%CI [2.1, 5.8]). ConclusionSix infusions of ketamine was associated with improvements in functional outcomes in adults with TRD and/or suicidality. Depressive symptoms severity and processing speed performance were significant partial mediators of objective and subjective functioning improvements.

Factors associated with antipsychotic use in non-psychotic depressed patients: results from a clinical multicenter survey

BackgroundThe combination of antipsychotics is not well studied among non-psychotic major depressive disorder (MDD). This study aims to explore the antipsychotics use in this population and its associated factors.MethodsThis cross-sectional and multi-site study was conducted in 11 sites of China. one Thousand five hundred three eligible MDD patients after 8–12 weeks of antidepressant treatment were included consecutively. A structured questionnaire was used to obtain socio-demographic data and medical histories. The Chinese version of the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR), the Patient Health Questionnaire-15 (PHQ-15) and the Sheehan Disability Scale (SDS) were used for patient self-rating. Logistic regression model was used to explore the associated factors that could potentially be influential for the use antipsychotic augmentation.ResultsOverall, quetiapine (43.4%) was the most commonly used as an adjunct to antidepressants, followed by olanzapine (38.8%). And antipsychotics were commonly combined with escitalopram (23.1%), venlafaxine (21.7%), sertraline (14.8%). The factors influencing the combination of antipsychotics in non-psychotic depressed patients included service setting (OR = 0.444; p < 0.001; 95%CI = 0.338–0.583), comorbidity of physical illness (OR = 1.704; p < 0.001; 95%CI = 1.274–2.278), PHQ level (OR = 0.680; p < 0.001; 95%CI = 0.548–0.844), SDS level (OR = 1.627; p < 0.001; 95%CI = 1.371–1.930) and antidepressants co-treatment (OR = 2.606; p < 0.001; 95%CI = 1.949–3.485).ConclusionsAntipsychotics use is common among non-psychotic MDD patient. Service setting, comorbidity of physical illness, somatic symptoms, social functioning and engagement, and antidepressants co-treatment could be the factors associated with the antipsychotics use in MDD patients.

The impact of lurasidone on functioning and indirect costs in adults with bipolar depression: a post-hoc analysis

Objective The aim of this post-hoc analysis was to assess the impact of lurasidone monotherapy on functional impairment, productivity, and associated indirect costs in patients with bipolar depression. Methods Data were analyzed from a 6-week randomized, double-blind (DB; NCT00868699), placebo-controlled trial of lurasidone monotherapy and a 6-month open label extension (OLE; NCT00868959) study. Patients with bipolar depression who completed the 6-week DB trial were subsequently enrolled in the OLE. Analysis of the OLE was limited to patients who either continued lurasidone (LUR-LUR) or switched from placebo to lurasidone monotherapy (PBO-LUR). The Sheehan Disability Scale (SDS), which measures functional impairment and productivity, was collected at DB baseline, DB week 6/OLE baseline, OLE month 3, and OLE month 6. Annual indirect costs were calculated based on days lost or unproductive from work/school due to symptoms. Effect sizes (ES) in functioning and days lost/unproductive were reported for the DB trial and mean changes for the OLE. Results A total of 485 patients were enrolled in the DB trial (lurasidone: n = 323; placebo: n = 162) and 316 were in the lurasidone monotherapy group during the OLE (LUR-LUR: n = 210; PBO-LUR: n = 106). In the DB trial, improvements in functioning (work: ES = 0.36, p = .0071; social: ES = 0.55, p < .0001; family: ES = 0.50, p < .0001) were significantly greater for lurasidone compared to placebo. Reductions in days lost (ES = 0.33, p = .0050) and unproductive (ES = 0.45, p = .0001) were significantly higher for lurasidone vs. placebo. This resulted in a greater reduction in indirect costs for lurasidone vs. placebo (least squares mean (standard error) = −$32,322 ($2,100) vs. −$20,091 ($2,838)). Improvements in functioning and productivity were sustained during the 6-month OLE for both LUR-LUR and PBO-LUR. Conclusions Lurasidone monotherapy for the treatment of bipolar depression significantly improved functioning and reduced indirect costs vs. placebo at week 6. Significant improvements in functioning and productivity were sustained for 6 months for both LUR-LUR and PBO-LUR.

Development of a psychosocial functioning questionnaire for patients with major depressive disorder

BackgroundThe importance of psychosocial functioning in the assessment, diagnosis and treatment of major depressive disorder (MDD) is widely recognised. However, there is a lack of effective scales to assess psychosocial...