An investigator initiated, single center, single arm, open-label, cross- sectional study to assess clinical impact of adjunctive cariprazine in Indian patients with Major Depressive Disorder.
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in Montgomery–Åsberg Depression Rating Scale (MADRS) total scores
Study Overview
Brief Summary
This is an investigator initiated, single center, single arm, open-label, cross-sectional, study to assess clinical impact of adjunctive Cariprazine in Indian patients with Major Depressive Disorder
Known cases of MDD will be followed up with initial add-on cariprazine administered as 1.5 or 3 mg once daily as an adjunctive therapy to antidepressant for 12W. The minimum observation period will be of 12W.
Clinical cases of Difficult to treat depression showing incomplete response (<50% MADRS scores reduction) to SSRI monotherapy receiving Cariprazine.
Clinical cases receiving Cariprazine with follow-up data for 12 weeks.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All patients must meet all of the following criteria for enrollment in the study: 1) Clinical cases of Difficult to treat depression showing incomplete response (less than 50% MADRS scores reduction) to SSRI monotherapy receiving Cariprazine 2) Clinical cases receiving Cariprazine with follow-up data for 12 weeks.
Exclusion Criteria
- •If patient meeting any of the study exclusion criteria should be excluded from study 1) Clinical cases receiving Cariprazine with antecedent history or cause or diagnoses of personality disorder, comorbidities including bipolar disorder, schizophrenia, substance abuse disorder, dementia or other neurodegenerative diseases significantly impacting cognitive functioning, or mood disorders due to an underlying general medical condition 2) Patients currently receiving ECT or Psychotherapy since last six weeks.
Outcomes
Primary Outcomes
Change in Montgomery–Åsberg Depression Rating Scale (MADRS) total scores
Time Frame: 12 weeks
over baseline.
Time Frame: 12 weeks
Secondary Outcomes
- Remission rate (Clinical cases with MADRS total score less than equal to 10)
- Change in functioning using Sheehan Disability Scale (SDS) over baseline(12 weeks)
- Response rate (Reduction in the MADRS total score of at least 50%)(End of study period (90 days))
- Clinician Global Assessment for Efficacy Index (CGI-EI)(End of study period (90 days))
- Adverse event rate
Investigators
Dr Sagar Karia
Care 2 Cure Clinic