ASCEnD
Research type
Research Study
Full title
Aripiprazole/sertraline combination: clinical and cost-effectiveness in comparison with quetiapine for the treatment of bipolar depression. An open label randomised controlled trial.
IRAS ID
1007468
Contact name
Stuart Watson
Contact email
Sponsor organisation
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
ISRCTN Number
ISRCTN63917405
Clinicaltrials.gov Identifier
NA
Research summary
Bipolar disorder (BP) affects more than 1 person in 100, negatively impacts people’s lives and places a tremendous strain on caregivers, the NHS and society. It causes earlier than expected death, including by suicide. Depression is common in BP (“bipolar depression”).
People with unipolar depression usually improve with a standard antidepressant or talking therapy, but only specialist psychological treatments are recommended in BP. These aren’t widely available and haven’t convincingly been shown to treat bipolar depression. Similarly, in BP, antidepressant drugs, when taken by themselves, show no therapeutic value. In light of this, the National Institute of Clinical Excellence (NICE) largely recommends treatment with so called “antipsychotic” drugs. These are often poorly tolerated causing sedation, weight gain, sleep disturbance and diabetes. Most current treatment options are also only recommended to be started by psychiatrists. So, additional treatment options are needed and this has been identified by the James Lind Alliance (JLA) as a priority for patients.
A previous small trial indicated a combination of the antipsychotic aripiprazole with an antidepressant may be effective in bipolar depression, with a reduced burden of side-effects compared to current treatments. It is time now for a large trial to see if this combination works.
270 adults with bipolar depression from primary and secondary care services will be randomised to receive aripiprazole/sertraline combination, or quetiapine. We will follow participants up for 24 weeks using questionnaires to examine any longer-term benefit on depressive symptoms, quality of life and costs. 10 NHS trusts will take part in the study.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
23/NE/0132
Date of REC Opinion
22 Nov 2023
REC opinion
Further Information Favourable Opinion