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To find out the effect of Cariprazine versus Aripiprazole as an add on treatment in adults with Depression on Escitalopram.

Efficacy and Safety of Cariprazine versus Aripiprazole as an add-on therapy in adults with Major Depressive Disorder on Escitalopram.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049390
Enrollment
60
Registered
2023-02-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: F331- Major depressive disorder, recurrent, moderate

Interventions

Intervention1: Cap Cariprazine: Cap Cariprazine 3mg/day once daily will be given as an add on therapy for 6 weeks to a group of patients of Major depressive Disorder on Tab Escitalopram 20mg/day. Enro

Sponsors

Pt B.D. Sharma PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient presenting with DSM-V depressive episode for the first time. 2. HAM-D score of 14 or more on the 17-item version on day 0 of the study. 3. Age 18 years and above. 4. Any Gender. 5. Patient showing partial response( HAM-D score of 14 or more) to Escitalopram up to a dose of 20mg/day for the past 6 weeks.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of depression with psychotic features or any other psychiatric diagnosis in the past. 2. Patient with a history of any chronic physical illness. 3. Current psychoactive substance use disorders except for tobacco. 4. Pregnant women and lactating mothers. 5. Patients becoming accidentally pregnant or desiring pregnancy during the study period. 6. Patient with a history of allergy to or not able to tolerate study drugs. 7. Inability to come for regular follow-ups. 8. Active suicidal ideation or other safety concerns. 9. Exposure to drugs that have interaction with study drugs.

Design outcomes

Primary

MeasureTime frame
1. Clinical response according to HAMD-17, determined by 50% or more reduction in scale scores. 2. Severity of illness and improvement using Clinical Global Impression Scale(CGI).Timepoint: Participants will be assessed initially for baseline parameters and followed up at 2,4,6 weeks using HDRS and CGI scales.—

Secondary

MeasureTime frame
1. Presence and intensity of suicidal thoughts using the Suicidal Ideation Attributes Scale (SIDAS). 2. Quality of life in patients of depression using the WHOQOL-BREF scale.Timepoint: Participants will be assessed initially for baseline parameters and followed up at 2,4,6 weeks using SIDAS and WHOQOL-BREF scales.—

Countries

India

Contacts

Public ContactDr Harsh Vasistha

Pt. B.D. Sharma PGIMS Rohtak

vasisthaharsh@gmail.com9996321909

Outcome results

None listed

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