Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder

Sponsor
Sultan Qaboos University
Study ID
NCT05933538
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cariprazine — DRUG
    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.
  • Treatment as usual — COMBINATION_PRODUCT
    Participants in this will receive either antidepressants including SSRI, SNRI or TCA or for psychotherapy alone or a combination of psychotherapy and antidepressants.

Study Details

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.

Key Dates

Start date
Aug 31, 2024
Status verified
Jul 2023
Primary completion
Aug 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cariprazine monotherapy
  • Active Comparator: Treatment as usual

Primary Outcome Measure

Montgomery-Asberg Depression Rating Scale [ Time Frame: 8 weeks ]

Central Contacts

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