Aripiprazole/Sertraline Combination: Clinical and Cost‐Effectiveness in Comparison With Quetiapine for the Treatment of Bipolar Depression (ASCEnD Trial)—Protocol for a Nested Qualitative Study

Hoppe, Isobel; Watson, Stuart; Kemp, Caroline; Turnbull, Fiona; Davies, Firoza; Gibson, John; Azim, Lumbini; Wall, Lauren; Ahuja, Niraj; Al‐Ashmori, Sarah; Keys, Sally; Kabir, Thomas; Chew‐Graham, Carolyn A.

Abstract

Introduction
Bipolar disorder is a recurrent mental health disorder with a prevalence rate of 1.4%. On average, there can be a delay of 9.5 years from the initial presentation of symptoms to a confirmed diagnosis. Individuals living with bipolar disorder have a reduced life expectancy. There is limited evidence regarding the effectiveness of antidepressants in treating bipolar disorder. The ASCEnD clinical trial will test the clinical and cost-effectiveness of the aripiprazole/sertraline combination in comparison with quetiapine for the treatment of bipolar depression (individuals who suffer from depressive episodes in bipolar disorder) and will include a nested qualitative study.

Methods
The qualitative study will use semi-structured interviews to explore pilot trial participants' and clinicians' perspectives on recruitment procedures, the acceptability of the intervention, the management of bipolar disorder and attitudes to medication combinations.

Conclusion
Findings will inform recruitment strategies and optimise training for the participating sites in the ASCEnD full trial. They will also help to illuminate the lived experience of people with bipolar disorder and the clinicians who work with people with bipolar disorder. The discussion will explore perspectives on the delay in diagnosis, having a diagnosis, the impact of living with bipolar disorder and attitudes to treatment, including drug combinations.

Patient or Public Contribution
A Lived Experience Advisory Panel (LEAP) has been convened with the support of the McPin Foundation, which will contribute to the ASCEnD trial and its nested qualitative study to provide input on the design and delivery of the trial and qualitative study, analysis of qualitative data and dissemination of findings.

Citation

Hoppe, I., Watson, S., Kemp, C., Turnbull, F., Davies, F., Gibson, J., Azim, L., Wall, L., Ahuja, N., Al‐Ashmori, S., Keys, S., Kabir, T., & Chew‐Graham, C. A. (2024). Aripiprazole/Sertraline Combination: Clinical and Cost‐Effectiveness in Comparison With Quetiapine for the Treatment of Bipolar Depression (ASCEnD Trial)—Protocol for a Nested Qualitative Study. Health Expectations, 27(5), Article e70018. https://doi.org/10.1111/hex.70018

• Journal Article Type: Article
• Acceptance Date: Aug 20, 2024
• Online Publication Date: Sep 4, 2024
• Publication Date: Oct 1, 2024
• Deposit Date: Sep 9, 2024
• Publicly Available Date: Sep 9, 2024
• Journal: Health Expectations
• Print ISSN: 1369-6513
• Electronic ISSN: 1369-7625
• Publisher: Wiley
• Peer Reviewed: Peer Reviewed
• Volume: 27
• Issue: 5
• Article Number: e70018
• DOI: https://doi.org/10.1111/hex.70018
• Keywords: clinical trial, mental health, bipolar disorder, bipolar depression, nested qualitative study, patient and public involvement
• Public URL: https://keele-repository.worktribe.com/output/891953
• Publisher URL: https://onlinelibrary.wiley.com/doi/10.1111/hex.70018