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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]

Background: It is over the last decade that research in this field of domestic violence has led to greater recognition of the issue as public health problem. The paper aims to study the prevalence of physical, psychological, and sexual violence and potential risk factors of the women confronting violence within the home in India. Materials and Methods: A multicentric study with analytical cross-sectional design was applied. It covers 18 states in India with 14,507 women respondents. Multistage sampling and probability proportion to size were done. Results: The result shows that overall 39 per cent of women were abused. Women who have a lower household income, illiterate, belonging to lower caste, and have a partner who drinks/bets, etc. found to be important risk factors and place women in India at a greater risk of experiencing domestic violence. Conclusion: As India has already passed a bill against domestic violence, the present results on robustness of the problem will be useful to sensitize the concerned agencies to strictly implement the law. This may lead to more constructive and sustainable response to domestic violence in India for improvement of women health and wellbeing. [ABSTRACT FROM AUTHOR]