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.
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).
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.
Pregnant, lactating, or of childbearing potential and not willing to use an approved method of contraception during the study.
Parallel
Cariprazine
DrugThe 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 productParticipants in this will receive either antidepressants including SSRI, SNRI or TCA or for psychotherapy alone or a combination of psychotherapy and antidepressants.
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
Change in Clinical Global Impression Scale (CGI) Mean Score [ Time Frame: 8 weeks ]
The secondary outcome measure will be the change in clinical global impression as measured by the CGI, which will be completed at baseline, week 2, week 4, and week 8
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