Bipolar depression Mental and Behavioural Disorders
Conditions
Interventions
The ASCEnD trial is a prospective, two-arm, open-label, superiority, individually 1:1 randomised, controlled, pragmatic, parallel-group, type A open-label clinical trial. It aims to determine whether
Sponsors
Cumbria Northumberland Tyne and Wear NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must fulfil all of the following criteria to progress to randomisation: 1. Aged 18 years old and 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) confirmed diagnosis of a major depressive episode within bipolar disorder. This will be confirmed using the SCID-5-RV. 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
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. 3. Any known contraindications to aripiprazole, sertraline or quetiapine. 4. Currently pregnant, planning to become pregnant during the trial and/or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in depression measured using the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) weekly following randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the impact of the aripiprazole/sertraline combination versus quetiapine on the following secondary outcomes: 1. The trajectories of symptom change, measured via the QIDS-SR reported weekly from screening 2. Treatment satisfaction, measured via the Treatment Satisfaction Questionnaire for Medication (TSQM) at baseline and weeks 4, 14 and 24 3. Tolerability, measured via the Glasgow Antipsychotic Side-effect Scale (GASS) at baseline and weeks 4, 14 and 24 4. Pattern of medication adherence, measured via weekly questions in ePro regarding dosages of study medications taken on each of the preceding 7 days. This will be supported by the use of the Medication Adherence Rating Scale (MARS) at baseline and weeks 4, 14 and 24. 5. Pattern of non-randomised antidepressant/antipsychotic medication use, measured via analysis of concomitant medications weekly from screening 6. Change in anxiety symptoms, measured via the General Anxiety Disorder-7 (GAD-7) scale weekly from baseline 7. Change in manic symptoms and rates of relapse to a hypomanic or manic episode, measured via the Altman Self-Rating Mania Scale (ASRM) weekly from baseline 8. Psychosocial functioning, measured via the Work and Social Adjustment Scale (WSAS) at baseline and weeks 4, 14 and 24 9. Health-related quality of life, measured via the EQ-5D-5L questionnaire weekly from baseline 10. Capability well-being, measured via the ICEpop CAPability measure for Adults (ICECAP-A) and the Oxford CAPabilities Questionnaire-Mental Health (OxCAP-MH) at baseline and weeks 4, 14 and 24 11. Costs and incremental cost-effectiveness, based on the Health Economics Questionnaire (HEQ), measured at baseline and weeks 4, 14 and 24 12. Informal carers’ health-related quality of life, capability well-being and costs of caring measured via the EQ-5D-5L, the ICEpop CAPability measure for Adults (ICECAP-A), the Oxford CAPabilities Questionnaire-Mental Health (OxCAP-MH) and the Caregiver Indirect and Informal Care Cost Assessme | — |
Countries
England, United Kingdom
Contacts
Public ContactASCEnD Trial Management Team
Outcome results
None listed