A clinical trial to study the effects of two drugs, Agomelatine and Venlafaxine ER in patients with major depressive disorder.
- Conditions
- Health Condition 1: null- Major Depressive Disorder
- Registration Number
- CTRI/2011/04/001659
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average change from baseline in Hamilton Depression Rating Scale (HAM-D) total score <br/ ><br> <br/ ><br>Timepoint: Day 0, Day 14, Day 28, Day 42. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Response to treatment <br/ ><br>2. Average change from baseline to end of study in Clinical Global Impression on Severity (CGI-S). <br/ ><br>3. Clinical Global Impression on Improvement (CGI-I) in patients. <br/ ><br>Timepoint: 1. Day 42. <br/ ><br>2. Day 0, Day 42 <br/ ><br>3. Day 14, Day 28, Day 42 <br/ ><br>