A Multicentric, Open-label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Efficacy and Safety of Agomelatine oral tablets in patients with Major Depressive Disorder

Precise Chemipharma Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•All subjects with duly filled and signed in ICFs [Informed Consent Forms].
•Adult males or females, age 18-65 years (inclusive).
•Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria.
•HAM-D17 total score less than or 22 at Screening and Baseline.
•CGI-Severity score less than or 4 at Screening and Baseline.
•Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase.

•Patients with seasonal patterns, psychotic features or post-partum onset. Patients with other types of depression or psychiatric conditions (including bipolar I and II or dysthymic disorders) and those who displayed marked suicidal intent or known suicidal tendencies.
•Patients undergoing electroconvulsive treatment, insight-oriented or structured psychotherapy during the 3 months prior to assessment. Patients undergoing light therapy during the 2 weeks before assessment.
•Patients who are otherwise eligible but who had not derived clinical benefit from two adequate antidepressant trials for the current episode, or from a previous trial of Agomelatine, will also be excluded.
•History of schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder.
•Any current Axis I disorder other than major depressive disorder which is the focus of treatment.
•Substance or alcohol abuse in the last 30 days, dependence in the last 6 months.
•Concomitant psychotropic medication, including herbal preparations and melatonin.
•Psychotherapy of any type.
•Female patients of childbearing potential who are not using effective contraception.

发起方

Precise Chemipharma Pvt Ltd