School of Medicine, Keele University, Newcastle, UK.
Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Health Expect. 2024 Oct;27(5):e70018. doi: 10.1111/hex.70018.
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.
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.
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.
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.
双相情感障碍是一种反复发作的精神健康障碍，患病率为 1.4%。平均而言，从症状首次出现到确诊可延迟 9.5 年。患有双相情感障碍的个体预期寿命会缩短。关于抗抑郁药治疗双相情感障碍的有效性的证据有限。ASCEnD 临床试验将测试阿立哌唑/舍曲林联合用药与喹硫平治疗双相抑郁（双相情感障碍中出现抑郁发作的个体）的临床和成本效益，并将包括一项嵌套式定性研究。
定性研究将使用半结构化访谈，探索试点试验参与者和临床医生对招募程序、干预措施的可接受性、双相障碍的管理以及对药物联合使用的态度的看法。
研究结果将为 ASCEnD 全试验的招募策略提供信息，并优化参与地点的培训。它们还将有助于阐明双相情感障碍患者和与双相情感障碍患者合作的临床医生的生活体验。讨论将探讨对诊断延迟、诊断、与双相情感障碍共存的影响以及对治疗的态度，包括药物联合使用的看法。
在 McPin 基金会的支持下，成立了一个生活体验咨询小组（LEAP），该小组将为 ASCEnD 试验及其嵌套式定性研究做出贡献，为试验和定性研究的设计和实施、定性数据分析和研究结果的传播提供投入。
