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Introduction: This paper describes a fictitious study of a fictitious drug. A companion paper in this issue of the Indian J Psychiatry critically examines this paper and provides author, reader, reviewer, and researcher perspectives on problems related to the design and conduct of a clinical trial; on issues related to the analysis of data; on how to write a research paper; and on how to critically read or review a journal article. Readers are invited to appraise this paper and then compare their assessment with that presented in the companion paper. Background: This study sought to compare the safety and efficacy of placeboxetine (PB) hydrochloride extended release capsules with sertraline hydrochloride in patients diagnosed with major depressive disorder in 15 general hospitals in south India. Materials and Methods: In a prospective, open-label, 15-center, randomized controlled clinical trial, consecutive outpatients diagnosed with major depressive disorder of at least moderate severity were randomized 1:1 to receive flexible doses of either PB or sertraline once each morning. Patients were evaluated every two weeks, until the study endpoint, using the Hamilton Rating Scale for Depression (HAM-D) and the Montgomery-Asberg Rating Scale (MADRS). Safety was determined through assessments of vital signs, adverse events, study discontinuation rates, hematological parameters, metabolic parameters, electrocardiography, and other measures. Results: Ten patients dropped out of the study from each treatment arm. There was a significant, marked improvement in HAM-D and MADRS scores in each group by the treatment endpoint. There was no significant difference between PB and sertraline groups on either HAM-D or MADRS at any visit. The response rate was 90% with PB and 92% with sertraline. The remission rate was 70% with PB and 75% with sertraline. All laboratory parameters were within normal limits in all patients. There were no serious adverse events. Conclusions: Placeboxetine is as safe and effective as sertraline in Indian patients with major depressive disorder. [ABSTRACT FROM AUTHOR]

Aim: This study aimed to evaluate the disability and its correlates in persons with Bipolar Disorder during the remission phase. Materials and Methods: As part of the multicentric study, 773 patients with bipolar disorder, currently in clinical remission, were evaluated for disability on the Indian Disability Assessment Evaluation Scale. Results: About one-fifth of the participants had some level of disability in the domain of self-care, one-third had some level of disability in the interpersonal domain, one-fourth had some level of disability in communication and understanding, and a maximum proportion (43.7%) had some disability in the domain of work. Overall, about one-fifth (18.4%) were considered to have a benchmark disability (i.e., disability >40%). In terms of correlates, those with a disability had a short duration of current remission, a higher number of manic and mixed episodes, a higher mean number of total episodes, spent more time in the episodes, had lower severity of the depressive episodes, higher residual depressive and manic symptoms, had overall higher manic affective morbidity, had a higher level of cognitive deficits, and had poorer insight. Conclusion: A significant proportion of patients with bipolar disorder have disability in work domain, and the presence of residual symptoms of either polarity are associated with higher level of disability. [ABSTRACT FROM AUTHOR]

Aim: To study the health-care needs of the patients with severe mental disorders as perceived by their family caregivers and the treating psychiatrists. Materials and Methods: Caregivers of patients with severe mental disorders and their treating psychiatrists were assessed using Camberwell Assessment of Need-Research Version (CAN-R) scale and indigenously designed Supplementary Assessment of Needs Scale (SNAS). Results: The study included 1494 patients recruited from 15 centers. The mean needs as per the CAN-R, perceived by the caregivers were 7.8 and treating psychiatrists were 8.1. About one-third of needs were unmet. On SNAS, both caregivers and treating psychiatrists reported a mean of 7.9 needs, of which more than half were unmet as per the caregivers. As per the treating psychiatrists, 45.5% of the needs as assessed on SNAS were unmet. There was a high level of correlation between needs perceived by the patients, caregivers and the treating psychiatrists. On CAN-R, main domains of needs as reported by the caregivers were those of money, relief of psychological distress, information about the illness and treatment, welfare benefits, transport, company and food. As per the treating psychiatrists, the most common total needs identified were those of relief of psychological distress, welfare benefits, information about the illness and treatment, money, transport, company self-care and physical health. The most common domains of needs as assessed on SNAS as per the caregivers were those of free treatment, medical reimbursement, psychoeducation, financial help, social support, insurance, more time from the clinicians and travel concession. The treating psychiatrists identified dealing with caregiver's stress as the most common need. Conclusions: According to the family caregivers and treating psychiatrists, about one-third of the needs of the patients as assessed using CAN-R and about half of the needs as assessed using SNAS are unmet. [ABSTRACT FROM AUTHOR]