Pharmacogenetic-Guided Antidepressant Treatment for Major Depressive Disorder: A Randomized Controlled Trial in Morocco
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 570
- 试验地点
- 1
- 主要终点
- Depression Severity
研究概览
简要总结
The purpose of this clinical trial is to evaluate whether using pharmacogenetic testing to guide antidepressant treatment can improve outcomes in adults with major depressive disorder in Morocco. Depression is a common mental health condition, and finding the most effective antidepressant for a patient can take time. Some individuals do not respond well to the first medication prescribed or may experience side effects.
Pharmacogenetic testing examines genetic variations that can influence how a person processes certain medications. Information about genes involved in drug metabolism, such as CYP2D6 and CYP2C19, may help clinicians choose antidepressants and adjust doses more appropriately for each patient.
The main question this study aims to answer is whether treatment guided by pharmacogenetic test results leads to higher remission rates of depressive symptoms compared with usual clinical care.
In this study, participants diagnosed with major depressive disorder will be randomly assigned to one of two groups. In the pharmacogenetic-guided group, clinicians will receive the patient's genetic test results and may use this information to guide antidepressant selection and dosing. In the usual care group, antidepressant treatment will be prescribed according to standard clinical practice without access to pharmacogenetic information.
Participants will receive antidepressant treatment and will be followed for 12 weeks. During this period, depressive symptoms will be evaluated using standardized clinical questionnaires, including the Patient Health Questionnaire (PHQ-9). Information on treatment response, medication tolerance, and adverse effects will also be collected.
This study aims to provide evidence on the potential role of pharmacogenetic-guided treatment in improving depression management and to support the development of personalized medicine approaches in psychiatric care in Morocco.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a depressive disorder (major depressive disorder, depressive episode, or persistent depressive disorder) confirmed by a healthcare professional according to DSM-5 or ICD-10 criteria.
- •Aged 18 years or older at the time of enrollment.
- •Clinical indication for initiation or modification of antidepressant pharmacotherapy.
- •Ability to understand study procedures and provide written informed consent.
排除标准
- •Inability to provide informed consent.
- •Current acute psychotic disorder, manic episode, or uncontrolled bipolar disorder.
- •Current pregnancy or breastfeeding.
- •Use of medications with clinically significant interactions with antidepressants.
- •Any severe medical condition that, in the opinion of the investigator, would compromise participant safety or study integrity.
研究组 & 干预措施
Pharmacogenetic-Guided Treatment
干预措施: Pharmacogenetic-Guided Treatment (Diagnostic Test)
Usual Care
Participants receive standard antidepressant treatment according to routine clinical practice without access to pharmacogenetic test results.
干预措施: Usual Care (Other)
结局指标
主要结局
Depression Severity
时间窗: 12 weeks post-randomization
Severity of depressive symptoms assessed using the 17-item Hamilton Depression Rating Scale (HAM-D17), a clinician-rated scale ranging from 0 to 52, where higher scores indicate greater depression severity and worse outcomes. The outcome will be analyzed as the change in HAM-D17 total score from baseline to 12 weeks post-randomization. A greater decrease in score reflects greater clinical improvement.
Depression Remission
时间窗: 12 weeks post-randomization
Depression remission assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a self-reported scale ranging from 0 to 27, with lower scores indicating lower depression severity. Remission is defined as a PHQ-9 score ≤5 at 12 weeks after randomization.
次要结局
- Depression Response(12 weeks post-randomization)
- Medication Tolerability(12 weeks post-randomization)
- Global Clinical Improvement(12 weeks post-randomization)
- Depression Remission(12 weeks post-randomization)
- Depression Severity(12 weeks post-randomization)
研究者
Atarki Meriem
PhD Candidate
Mohammed V University in Rabat