A clinical trial to study the effects of two drugs, Agomelatine and Venlafaxine ER in patients with major depressive disorder.

Evaluation of efficacy and safety of agomelatine versus venlafaxine ER in the treatment of major depressive disorder : a randomized, open - label, comparative, active controlled, multi-centre trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/04/001659

Enrollment

200

Registered

2011-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Major Depressive Disorder

Interventions

Intervention1: Agomelatine: 25 mg to 50 mg per day orally for 6 weeks Control Intervention1: Venlafaxine ER: 37.5 mg to 150 mg per day orally for 6 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients age between 18 and 65 years. 2. Has a primary diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV). 3. Has a Hamilton Depression rating Scale (HAM?D) total score more than or equal to 22. 4. Patient willing to give their informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating woman and woman of childbearing potential who are not using contraceptives. 2. Patients having hypersensitivity to Agomelatine, Venlafaxine or any of the excipients of this formulation. 3. Patients taking monoamine oxidase inhibitors (MAOIs). 4. Patients who displayed marked suicidal intent or known suicidal tendencies. 5. Alcohol abused patients. 6. Patients who have a history of glaucoma or a history of increased intraocular pressure. 7. Patients taking SSRI, SNRI or 5HT receptor agonists. 8. Patients undergoing the electroconvulsive treatment. 9. Patients had received insight oriented or structured psychotherapy during the 3 months prior to assessment. 10. Patients undergoing the light therapy during the 2 weeks before the assessment. 11. Has an abnormal electrocardiogram. 12. Has a serum creatinine of more than 1.5 x upper limit of normal. 13. Has thyroid stimulating hormone value outside the normal range.

Design outcomes

Primary

Measure	Time frame
Average change from baseline in Hamilton Depression Rating Scale (HAM-D) total score Timepoint: Day 0, Day 14, Day 28, Day 42.	—

Secondary

Measure	Time frame
1. Response to treatment 2. Average change from baseline to end of study in Clinical Global Impression on Severity (CGI-S). 3. Clinical Global Impression on Improvement (CGI-I) in patients. Timepoint: 1. Day 42. 2. Day 0, Day 42 3. Day 14, Day 28, Day 42	—

Countries

India

Contacts

Public ContactDr Surendra Borgharkar

Sun Pharmaceutical Industries Ltd.

medical.services@sunpharma.com02266969696

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026