Use of Cariprazine drug in Indian patients having Major Depressive Disorder

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. - BOOST

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/01/062163

Enrollment

100

Registered

2024-01-31

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F321- Major depressive disorder, singleepisode, moderate

Interventions

Intervention1: Capsule Cariprazine (1.5 mg, 3 mg, 4.5 mg, 6 mg): Capsule Cariprazine has to be administered orally at initial dose of 1.5 mg per day. In patients reporting less than 20% MADRS scores r

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change in Montgomery–Åsberg Depression Rating Scale (MADRS) total scores over baseline.Timepoint: 12 weeks	—

Secondary

Measure	Time frame
Adverse event rate Timepoint: Day 14, Day 28, Day 56, Day 90;Change in functioning using Sheehan Disability Scale (SDS) over baselineTimepoint: 12 weeks;Clinician Global Assessment for Efficacy Index (CGI-EI)Timepoint: End of study period (90 days);Remission rate (Clinical cases with MADRS total score less than equal to 10) Timepoint: End of study period (90 days);Response rate (Reduction in the MADRS total score of at least 50%)Timepoint: End of study period (90 days)	—

Measure

Time frame

Adverse event rate Timepoint: Day 14, Day 28, Day 56, Day 90;Change in functioning using Sheehan Disability Scale (SDS) over baselineTimepoint: 12 weeks;Clinician Global Assessment for Efficacy Index (CGI-EI)Timepoint: End of study period (90 days);Remission rate (Clinical cases with MADRS total score less than equal to 10) Timepoint: End of study period (90 days);Response rate (Reduction in the MADRS total score of at least 50%)Timepoint: End of study period (90 days)

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Countries

India

Contacts

Public ContactDr Krishnaprasad K MD

Care 2 Cure Clinic

drsagarkaria@gmail.com9594530457

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026