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Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder

NCT05933538 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-07-07

No results posted yet for this study

Summary

This trial protocol aims to evaluate the effectiveness and safety of cariprazine monotherapy compared to treatment as usual for major depressive disorder (MDD) in a pragmatic open-label randomized controlled trial (RCT) conducted at Sultan Qaboos University Hospital Department of Behavioral Medicine. The protocol adheres to the guidelines outlined in Good Clinical Practice (GCP) and will be submitted to the Institutional Review Board (IRB) for approval. The trial will assess the efficacy of cariprazine in improving depressive symptoms and overall functioning, as well as its safety profile in patients with MDD.

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Cariprazine

The starting dose is 1.5 mg once daily which will be titrated according to the treating psychiatrist who assessing the response with maximum dose of 4.5mg. The dose to be escalated on 2 weekly interval.

COMBINATION_PRODUCT

Treatment as usual

Participants in this will receive either antidepressants including SSRI, SNRI or TCA or for psychotherapy alone or a combination of psychotherapy and antidepressants.

Sponsors & Collaborators

  • Sultan Qaboos University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2030-08-31
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05933538 on ClinicalTrials.gov