Clinical and cost-effectiveness of an aripiprazole and sertraline drug combination in comparison with the drug quetiapine for the treatment of bipolar depressio
- Conditions
- Bipolar depressionMental and Behavioural Disorders
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 270
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method