Study overview
The ASCEnD trial is an open label, 1:1 randomised, controlled, pragmatic trial which compares the clinical and cost-effectiveness of an aripiprazole and sertraline combination with quetiapine in the treatment of bipolar depression. The study is led by Dr Stuart Watson of Newcastle University and Cumbria, Northumberland, Tyne & Wear NHS Foundation Trust.
What is the ASCEnD Study?
Antidepressants can be very effective in people experiencing unipolar depression and can be prescribed by a GP. However, currently there is limited evidence regarding the effectiveness of antidepressants in individuals living with bipolar depression.
The ASCEnD study will allow us to determine which of the two existing treatments are most effective for people experiencing bipolar depression.
The ASCEnD study explained by Dr Stuart Watson, ASCEnD Chief investigator.
ASCEnD study medications
In this study we will use a combination of an antidepressant (sertraline) and an antipsychotic (aripiprazole) and compare this combination with an antipsychotic medication called quetiapine, which is a commonly used treatment for people experiencing depression in bipolar disorder.
All three medications are currently used in the NHS, but we want to find out if using a sertraline and aripiprazole combination will be beneficial in reducing depressive symptoms in people with bipolar.
The ASCEnD Study medications explained by Dr Apoorva Peddada, ASCEnD study doctor at CNTW
We are looking to recruit 270 participants diagnosed with bipolar disorder who are currently experiencing depression from across England to take part in the ASCEnD study.
Throughout the study, participants will be followed for 24 weeks using online questionnaires and weekly phone calls to measure improvement in depressive symptoms, quality of life and costs.
The ASCEnD Study Process
The ASCEnD study process explained by Dr Apoorva Peddada, ASCEnD Study doctor at CNTW.
What are the possible benefits and risks of participating?
The study team think there are minimal risks to being part of this study as all the medications are currently used in the NHS.
However, all medications carry some risks. Some of the common side effects of these drugs may include headaches, weight gain, feeling sleepy and nausea.
Participants will be in regular contact with study central research assistants and asked to report side effects they may experience via ePRO and discuss these with an investigator at their participating site.
If at any point during the study, the investigator thinks it would be beneficial for a participant to stop taking part, they will be withdrawn.