Newcastle Clinical Trials Unit


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