NCT05933538Not yet recruitingPhase 4
Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder
Effectiveness and Safety of Cariprazine Monotherapy Versus Treatment as Usual for Major Depressive Disorder: A Pragmatic Open Label Randomized Controlled Trial at Sultan Qaboos University Hospital Department of Behavioral Medicine
Source: ClinicalTrials.gov · Last updated 7 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 26 Jun 2023
- Start date
- Aug 2024
- Primary completion date
- Aug 2030
- Lead sponsor
- Sultan Qaboos University
- Diseases
- Depression
- NCT number
- NCT05933538
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 110
- From Aug 2024 to the primary completion date, Aug 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Pregnant, lactating, or of childbearing potential and not willing to use an approved method of contraception during the study.
Who the study is looking for
- 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).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.