ASCEND
Aripiprazole/ sertraline combination: a non-inferiority design in comparison with quetiapine in bipolar depression. An open label randomised controlled trial.
- Study stage: Set-up
- Sponsor: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
- Funder: NIHR and Care Reserch. Call: 19/130 Bipolar Disorder NIHR Healt Technology Assessment Programme
- Therapeutic area: Mental Health
- Type of study:CTIMP
Aim: To test the hypothesis that improvement in depression will be greater in participants randomised to aripiprazole/sertraline combination than those randomised to quetiapine.
Primary Outcome: The Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) reported weekly, 12 to 16 weeks after randomisation in the two arms analysed as repeated measures, adjusted for baseline, using intention to treat principles.
- Population: Adults
- Design: RCT
- Phase: III
- Setting: Secondary Care
- Planned Sample Size: 270