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.

Sun Pharmaceutical Industries 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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•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.

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