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