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ASCEnD - AriPIprazole/ sertraline combination

Overview

Study summary
“ASCEnD” is a clinical trial for people who have bipolar and are currently experiencing depression.
There are currently limited treatment options available for people with bipolar who have depressive symptoms. The ASCEnD trial will examine whether using two treatments together is better than standard single-drug treatment for bipolar. All of these drugs are already used in the NHS, and their safety profile is well known.
Who can take part?
You may be able to take part if you:
- Have bipolar
- Are currently depressed
- Are over the age of 18
- Not currently pregnant or breastfeeding or planning to become pregnant during the trial
Might I have bipolar?
Has there ever been a period when you were not your usual self and thoughts raced through your head or you couldn’t slow your mind down? If so, you will find more information on the BipolarUK website: www.bipolaruk.org/diagnosing-bipolar#could-it-be-bipolar.
What does the study involve?
Taking part will involve attending one or two face-to-face appointments (most likely one), to learn more about the trial and help you decide whether or not to take part, as well as confirming if you are eligible to take part. This will include completing some questionnaires, and discussing your medical history and medication.
If you agree to take part and are eligible, you will be randomly selected by a computer to start one of the trial treatments. If the treatment suits you and seems to be working then you will be able to continue it. If it isn’t, then you don’t need to, and you and your doctor can change to something else and you can still take part in the trial.
During the trial, you will be asked to complete a number of online questionnaires on a weekly basis, and you will receive a weekly phone call from a member of the research team for support.
You will be asked to take part in the trial for 24 weeks. You will be given up to £50 in vouchers, as a thank you for giving your time for the trial. You will be also reimbursed for reasonable travel costs for the in-person trial appointment(s).
Where can I take part?
The study is taking place at multiple sites across 10 Mental Health Trusts in England.
For more information
Please visit the study website: www.ascendtrial.co.uk/patient-homepage where you can get further information, register your interest for the trial and find out if you may be eligible to take part.
This study is being run with the support of the NHS and the National Institute for Health and Care Research (NIHR), working in partnership with Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust and Newcastle University.
If you are currently taking part in another study, please let the study team know when they contact you.

Interested in taking part in this study? Fill in this form.

Planned end date

31 Dec 2027 11:02

Conditions

Bipolar Disorder

Inclusion Criteria

Patients must fulfil all of the following criteria to progress to randomisation:

  1. Aged 18 or over at the point of consent.
  2. Able to provide written informed consent.
  3. A current (i.e., within 7 days) Diagnostic and Statistical Manual-5-Text Revision (DSM-5-TR) (153) confirmed diagnosis of a major depressive episode within bipolar disorder. This will be confirmed using the SCID-5-RV (153).
  4. A current (i.e., within 7 days) QIDS-SR greater than 10.
  5. Clinical uncertainty regarding the next course of treatment and judgement that the sertraline/aripiprazole combination and quetiapine treatment arms are both clinically appropriate and represent equipoise. This judgment includes consideration of reproductive risks.
  6. In the opinion of the clinician, the participant is able to follow trial prescription instructions, complete weekly questionnaires and engage in weekly telephone calls with the cRAs throughout the 24 week follow up period of the trial.

Exclusion Criteria

Any of the following criteria prevent progression to randomisation:

  1. Currently participating in any other interventional clinical trial that may affect the outcome of ASCEnD.
  2. DSM-5-TR defined severe substance use disorder (153).
  3. Any known contraindications to aripiprazole, sertraline or quetiapine.
  4. Currently pregnant, planning to become pregnant during the trial and/or breastfeeding.
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