Cariprazine as an add on agent in depression patients.

Study of Efficacy and Safety of Cariprazine Augmentation in Major Depressive Disorder - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/076064

Enrollment

Registered

2024-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic features

Interventions

Intervention1: Cariprazine 1.5mg: Sixty patients will be randomly divided into two groups A and B: Group A will receive 1.5mg Of caripraine Evaluations will be done at end of 2, 4 and 6 weeks. Interv

Eligibility

Inclusion criteria

Inclusion criteria: 1. DSM 5 criteria for Major depressive disorder. 2. Able to give consent. 3. MADRS score more than 20 despite adequate trial of one antidepressant. 4. patients on stable dose of same antidepressant for past 2 weeks.

Exclusion criteria

Exclusion criteria: 1. Patients who have bipolar depression, depression with psychotic features. 2. Any other comorbid psychiatric or medical diagnosis. 3. Not able to give consent. 4. Taking any other medications except benzodiazepine.

Design outcomes

Primary

Measure	Time frame
The severity of Depressive disorder which will be measured by percentage MADRS, HAMD score change from baseline and at the end of 6 weeks.Timepoint: 6 months	—

Secondary

Measure	Time frame
Response or remission rate will be calculated at each time point (2, 4 and 6 weeks) using MADRS and HAMD score.Timepoint: 6 months	—

Countries

India

Contacts

Public ContactDr Mohammed Reyazuddin

Jawaharlal Nehru Medical College

psychjnmc92@gmail.com9997258800

Outcome results

None listed

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