Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder

NCT05933538 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 133
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale

  Montgomery-Asberg Depression Rating Scale \[ Time Frame: 1-8 WEEKS \] Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline. Response: \>50% reduction in MADRS from baseline and a score \<22 Remission: MADRS ≤ 10

  8 weeks

Secondary Outcomes (1)

• Change in Clinical Global Impression Scale (CGI) Mean Score [ Time Frame: 8 weeks ]

  8 weeks

Study Arms (2)

Cariprazine monotherapy

EXPERIMENTAL

Drug: Cariprazine

Treatment as usual

ACTIVE COMPARATOR

Combination Product: Treatment as usual

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.

Cariprazine monotherapy

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.

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects meeting criteria for Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) currently in a Major Depressive Episode (MDE) as confirmed by the MINI International Neuropsychiatric Interview (MINI).
• A Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and at randomization, with no more than 20% improvement between these two visits.
• Female subjects of childbearing potential must have a negative urine pregnancy test at enrolment (Visit 1) and be willing to use a reliable method of birth control (i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation) during the study.
• Be able to understand and comply with the requirements of the study, as judged by the investigator(s).

You may not qualify if:

• Presence of a current or past history of psychotic symptoms or a diagnosis of schizophrenia or bipolar disorder.
• History of non-response or intolerance to Cariprazine or other antipsychotic medications.
• Concurrent use of other antipsychotic medications or medications known to interact with Cariprazine.
• Significant medical conditions or unstable medical conditions that could interfere with participation in the study or pose a risk to the participant's safety.
• Pregnant, lactating, or of childbearing potential and not willing to use an approved method of contraception during the study.

Sponsors & Collaborators

• Sultan Qaboos University: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

cariprazine; Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Mohammed Al Alawi, MD PhD MRCPsych

CONTACT

+96892281145; alalawim@squ.edu.om

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Dr Mohmmed Al Alawi Bsc, MD,PhD, MRCPsych, OMSBPsych, ARABPsych, Sultan Qaboos University

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 6, 2023
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share