Study of Efficacy and Safety of Cariprazine Augmentation in Major Depressive Disorder
Overview
- Phase
- Phase 3 4
- Status
- Completed
- Sponsor
- Dr Shreya Agrawal
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The severity of Depressive disorder which will be measured by percentage MADRS, HAMD score change from baseline and at the end of 6 weeks.
Overview
Brief Summary
This study aims to study the efficacy , safety and tolerability of Cariprazine as an adjunctive treatment in Major Depressive Disorder. Secondary objectives include comparing effects as well as adverse drug reactions of Cariprazine with different antidepressants. Conducted over 6 months at Jawaharlal Nehru Medical College, AMU, Aligarh, UP, this prospective, parallel arm , cross sectional study will include adult patients diagnosed with Major Depressive Disorder as per DSM-5 criteria. Participants will undergo comprehensive clinical history assessments and baseline evaluation using MADRS, HAMD scales. Sixty patients will be randomised into two groups : Group A will receive Cariprazine 1.5 mg and Group B will receive Cariprazine 3.0mg. Evaluation will be done at the end of 2, 4 and 6 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •DSM 5 criteria for Major depressive disorder.
- •Able to give consent.
- •MADRS score more than 20 despite adequate trial of one antidepressant.
- •patients on stable dose of same antidepressant for past 2 weeks.
Exclusion Criteria
- •Patients who have bipolar depression, depression with psychotic features.
- •Any other comorbid psychiatric or medical diagnosis.
- •Not able to give consent.
- •Taking any other medications except benzodiazepine.
Outcomes
Primary Outcomes
The severity of Depressive disorder which will be measured by percentage MADRS, HAMD score change from baseline and at the end of 6 weeks.
Time Frame: 6 months
Secondary Outcomes
- Response or remission rate will be calculated at each time point (2, 4 and 6 weeks) using MADRS and HAMD score.(6 months)
Investigators
Dr Shreya Agrawal
Jawaharlal Nehru Medical College, Aligarh Muslim University