ISRCTN63917405进行中（未招募）3 期
Aripiprazole/sertraline combination: clinical and cost-effectiveness in comparison with quetiapine for the treatment of bipolar depression. An open label randomised controlled trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients must fulfil all of the following criteria to progress to randomisation:
- •1. Aged 18 years old and over at the point of consent.
- •2. Able to provide written informed consent.
- •3. A current (i.e., within 7 days) Diagnostic and Statistical Manual-5-Text Revision (DSM-5-TR) confirmed diagnosis of a major depressive episode within bipolar disorder. This will be confirmed using the SCID-5-RV.
- •4. A current (i.e., within 7 days) QIDS-SR greater than 10.
- •5. Clinical uncertainty regarding the next course of treatment and judgement that the sertraline/aripiprazole combination and quetiapine treatment arms are both clinically appropriate and represent equipoise. This judgment includes consideration of reproductive risks.
- •6. In the opinion of the clinician, the participant is able to follow trial prescription instructions, complete weekly questionnaires and engage in weekly telephone calls with the cRAs throughout the 24-week follow-up period of the trial.
排除标准
- •Any of the following criteria prevent progression to randomisation:
- •1. Currently participating in any other interventional clinical trial that may affect the outcome of ASCEnD.
- •2. DSM-5-TR defined severe substance use disorder.
- •3. Any known contraindications to aripiprazole, sertraline or quetiapine.
- •4. Currently pregnant, planning to become pregnant during the trial and/or breastfeeding.
研究者
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