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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Montgomery-Asberg Depression Rating Scale
研究概览
简要总结
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.
详细描述
- Introduction:
Major Depressive Disorder (MDD) is a highly prevalent and debilitating psychiatric condition characterized by persistent feelings of sadness, loss of interest or pleasure, changes in appetite and sleep patterns, fatigue, and impaired concentration (American Psychiatric Association, 2013). It affects approximately 300 million people worldwide and is a leading cause of disability globally (World Health Organization, 2017). Despite the availability of various treatment options, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), a significant proportion of individuals with MDD experience inadequate response, residual symptoms, and functional impairment (Rush et al., 2006).
Cariprazine, an atypical antipsychotic, has shown efficacy in the treatment of bipolar depression (Citrome et al., 2013). It possesses a unique pharmacological profile, with partial agonist activity at D2 and D3 dopamine receptors and antagonist activity at serotonin 5-HT2A receptors (Durgam et al., 2016). The complex neurobiology of depression, involving multiple neurotransmitter systems, suggests that Cariprazine's mechanism of action may have therapeutic potential for MDD (Fava, 2016).
Literature review Several studies have explored the potential efficacy and safety of Cariprazine in the treatment of Major Depressive Disorder (MDD). While Cariprazine is currently approved for the treatment of bipolar depression, its effectiveness as a monotherapy for MDD remains an area of investigation.
A systematic review and meta-analysis by Durgam et al. (2016) evaluated the use of Cariprazine in bipolar depression, demonstrating its efficacy in improving depressive symptoms. Although the review focused on bipolar depression, the findings suggest that Cariprazine may hold promise for the treatment of depressive disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Cariprazine monotherapy
干预措施: Cariprazine (Drug)
Treatment as usual
干预措施: Treatment as usual (Combination Product)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale
时间窗: 8 weeks
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
次要结局
- Change in Clinical Global Impression Scale (CGI) Mean Score [ Time Frame: 8 weeks ](8 weeks)
研究者
Mohammed Al Alawi
Principal Investigator, Dr Mohmmed Al Alawi Bsc, MD,PhD, MRCPsych, OMSBPsych, ARABPsych, Sultan Qaboos University
Sultan Qaboos University