A clinical trial to study the effects of Agomelatine oral tablets in patients with Major Depressive Disorder

Phase 3

Recruiting

• Conditions: Health Condition 1: null- Major Depressive Disorder

• Registration Number: CTRI/2011/08/001946
• Lead Sponsor: Precise Chemipharma Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified