FAQs

You may be able to take part if you:

1. Have bipolar

2. Are currently experiencing depression

3. Are over the age of 18

4. Are not currently pregnant, breastfeeding or planning to become pregnant during the trial

The study is taking part across 9 mental health trusts in England. See the site page here for more information about our sites and how you can participate.

There are two main routes to participate in the ASCEnD Trial: through your care provider or through Research+Me. For more information about this click here.

The trial will last for 24 weeks and will require 1 or 2 face to face appointments which will cover the following:

1. Discussing the trial with a trial doctor who will answer any questions you may have before you decide whether or not to take part. If you decide to take part you will be asked to sign a consent form.

2. Confirming eligibiility through the completion of questionnaires and discussions about your past and current medications.

You can enter the trial if you and your doctor think that quetiapine or the aripiprazole and sertraline combination would be equally beneficial as your next treatment step. In the trial, you will be randomised electronically to start one of the treatment arms. If the treatment suits you and seems to be working, then you will be able to continue it after you complete the trial. If the treatment isn’t working for you then there is no requirement to continue the trial medication, and you will be able to remain within the trial on alternative medications that you decide with your doctor.

During the trial, you will be asked to complete a number of questionnaires on a weekly basis. This will be done electronically (or over the phone), and you will receive a weekly phone call from a member of the research team for support.

NICE currently recommends three treatments for the treatment of bipolar depression:

• Olanzapine (with or without fluoxetine)

• Quetiapine

• Lamotrigine

These drugs don’t work for everyone and can cause side effects. This highlights significant room for improvement of their medications. Participants will be closely monitored during the trial which will enable clinicians to adjust the medications to meet the needs of every individual participant.

The study has the potential to make a new safe and effective drug regime available for people with bipolar. To be eligible for ASCEnD, a participant must currently be experiencing depression.

Aripiprazole is already used to treat and prevent mania in bipolar. Unlike two of the NICE recommended treatments, aripiprazole is much less likely to cause weight gain, diabetes or raised cholesterol. It is also used in the treatment of depression in people who don’t have bipolar. In this case, it is usually combined with another anti-depressant such as an SSRI (Selective serotonin reuptake inhibitor).

Quetiapine is currently the most commonly used medication for the treatment of bipolar.

The ASCEnD study is designed to see whether a combination of aripiprazole with an SSRI (sertraline) is better than quetiapine in the management of bipolar depression.

You will be given up to £50, as a thank you for giving your time for the trial. You may be also reimbursed for reasonable travel costs during your participation.

For the purposes of this trial, prescribing should follow standard clinical practice. Quetiapine is available in both an immediate release (IR) and in an extended release (XL) formulation. The choice between IR and XL will be decided by the treating doctor for participants randomised to quetiapine to ensure tolerability and minimise side-effects. Modified release preparations include drugs with a coating which slows down the rate at which they are absorbed into the blood stream.

The maximum licensed dose of Aripiprazole for treatment of schizophrenia is 30mg daily but for the purpose of ASCEnD we are recommending much lower doses (2.5 to 10mg daily) as the evidence and clinical experience suggests these are more effective at treating bipolar depression.

The risk associated with changing from current medications for the study is no different to changing medication in routine clinical practice. The risk is minimised by offering support to treating clinicians by offering an ‘ASCEnD Medication Guide for Clinicians’ which outlines helpful practice.

The study does not require use of specific medication dosages or dose escalation procedures. Instead, clinicians are encouraged to use their judgement in accordance with clinical guidelines, the British National Formulary (BNF) dose schedule and this guidance. Dosage decisions and decisions regarding the ongoing use of study medications taken during the study remain the responsibility of the prescribing clinician who will make collaborative medication choices jointly with the patient.

 This study is being managed by Newcastle Clinical Trials Unit, sponsored by Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust and funded by the National Institute for Health and Care Research (NIHR).

The sponsor for this trial is the Research & Development department at Cumbria, Northumberland, and Tyne & Wear NHS Foundation Trust. The sponsor takes overall responsibility for the set-up, management and outcome of the clinical trial. Additionally, they are responsible for ensuring a clinical trial complies with legislation and Good Clinical Practice (GCP).

The qualitative sub-study has been designed in collaboration with researchers at Keele University to assess a number of factors related to the treatment of bipolar in various settings. Find out more about the qualitative study here.

The REWARD study an optional computerised decision-making task which is completed at three points during the trial. This will help us to better understand how the treatments work which may help to identify which participants are more likely to benefit from which treatment. For more information on the reward study click here.