CTRI/2019/11/022030
Completed
Phase 4
Comparative assessment of Safety and Efficacy of Vortioxetine with Escitalopram in patients with MDD: a randomized, comparative, parallel group, open-label study - MDD= Major Depressive Disorder
Dr Anshul Upadhyay0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: F339- Major depressive disorder, recurrent, unspecified
- Sponsor
- Dr Anshul Upadhyay
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients with primary diagnosed depression with MADRS (Montgomeryâ??Ã?sberg Depression Rating Scale) score \>22 and no other concurrent psychiatric disorders at baseline.
- •2\.Patients of 18 â?? 60 years of age
- •3\.Subjects of either gender
- •4\.Subjects willing to give written informed consent.
Exclusion Criteria
- •1\.Patients with history of substance abuse.
- •2\.Patients with two failed previous antidepressant treatments (of at least 6 weeks in duration)
- •3\.Patient with any other long\-term treatment like anti\-hypertensive, anti\-diabetic,
- •anti\-tubercular
- •4\.Patients with neurological disorders (dementia, stroke, seizures), obesity with
- •functional impairment, serious or not stabilized organic disorder (neoplastic,
- •cardiovascular, pulmonary, uncontrolled diabetes).
- •5\.Patients who pose a significant risk of suicide, had a score of 5 on item 10
- •(suicidal thoughts) of the MADRS or had made a suicide attempt in the previous 6 months.
- •6\.Patients who have received electroconvulsive therapy in the preceding 6 months.
Outcomes
Primary Outcomes
Not specified
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