Quetiapine effectiveness study in borderline personality disorder (QUEST)
| ISRCTN | ISRCTN16864220 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16864220 |
| IRAS number | 1010899 |
| Secondary identifying numbers | UoL00181894 |
- Submission date
- 05/03/2025
- Registration date
- 20/05/2025
- Last edited
- 20/05/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Borderline personality disorder (BPD) describes a collection of problems including negative feelings about self, fears of being let down, an acute sense of abandonment and rapid, distressing changes in mood. People with BPD find it difficult to maintain relationships, have high levels of mental health problems like depression and drug misuse, and high rates of self-harm and suicide. There are currently no drugs licensed for the treatment of BPD and clinicians are often unsure how best to help people with BPD.
Quetiapine is the most widely prescribed antipsychotic medication for BPD in the UK despite limited evidence that it works. There is only one published trial of quetiapine for BPD treatment which found that quetiapine was more effective than a ‘dummy tablet’ (placebo) in improving symptoms of BPD. However, the trial was short with a small number of participants so a longer and larger trial of quetiapine is required to see if these promising results can be repeated. It would be a very important finding and provide evidence for use of quetiapine to treat BPD. If the result does not provide evidence of the benefits of quetiapine, then clinicians would review whether treatment with quetiapine should be continued.
Who can participate?
We will recruit people in contact with mental health services in the NHS in regions in England that are under-represented in mental health research.
What does the study involve?
In this trial, people with BPD will be allocated, by chance, to receive either placebo or quetiapine for 12-months alongside their usual treatment. We will also examine any changes in cost that result from prescribing this drug and whether any changes in costs are worthwhile in terms of improvements in outcomes.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University of Liverpool (UK)
When is the study starting and how long is it expected to run for?
March 2025 to October 2028
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
questtrial@liverpool.ac.uk
Contact information
Public, Scientific
Liverpool Clinical Trials Centre, Block C, Waterhouse Building, 1-5 Brownlow Street
Liverpool
L69 3GL
United Kingdom
| questtrial@liverpool.ac.uk |
Principal Investigator
Parkbourn
Liverpool
L31 1HW
United Kingdom
| Phone | +44 151 472 4045 |
|---|---|
| inti.qurashi@merseycare.nhs.uk |
Study information
| Study design | Interventional double blind randomized parallel group placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Scientific title | The clinical and cost effectiveness of quetiapine for people with borderline personality disorder: A pragmatic, double-blind, placebo-controlled, randomised trial |
| Study acronym | QUEST |
| Study hypothesis | Primary objective: To test whether adding quetiapine to treatment as usual, in comparison to placebo and treatment as usual, improves the mental health of people with borderline personality disorder Secondary objectives: 1. To examine whether the addition of quetiapine improves social and occupational functioning, quality of life and reduces the incidence of suicidal behaviour in comparison to placebo and TAU 2. To compare the levels of adherence and the incidence of side-effects, including change in weight, amongst those prescribed quetiapine and those prescribed placebo. Economic Objective: To examine the cost, cost-effectiveness and cost-utility of adding quetiapine to TAU for adults with BPD in comparison to placebo and TAU. |
| Ethics approval(s) |
Approved 13/05/2025, West Midlands - Edgbaston Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048137; edgbaston.rec@hra.nhs.uk), ref: 25/WM/0052 |
| Condition | Borderline personality disorder |
| Intervention | Participants will be randomised (ratio 1:1) via a secure, 24-hour, web-based randomisation system controlled centrally by the LCTC to receive either quetiapine or matched placebo. Route of administration: oral IMP: Quetiapine prolonged release tablets (overencapsulated) in 50mg and 150mg. Dose: 150mg daily. Participants will be up titrated to this regime as follows: Week 1 – 50mg daily, Week 2- 100mg daily, Week 3 and onwards: 150mg daily Higher or lower doses will be permitted according to clinical response and tolerability (minimum dose of 50mg daily and maximum dose of 750mg daily) Placebo: Overencapsulated capsules filled with lactose to match IMP, in 50mg and 150mg. Dose: Same as IMP Trial treatment duration is 12 months |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacoeconomic, Therapy |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Quetiapine fumarate |
| Primary outcome measure | 1. Symptoms of BPD at 12 months using the total score on the ZAN BPD from baseline to 12 months |
| Secondary outcome measures | 1. Standardised Assessment of Personality Abbreviated Scale at 12 months using SAPAS at baseline and 12 months 2. Total score on the ZAN-BPD over 12 months measured at baseline, 3, 6, 9 and 12 months 3. Total score on the 21 item Beck Depression Inventory at baseline, 3, 6 and 12 months. 4. Mood Instability using the Affective Lability Scale – Short Form at baseline, 3, 6 and 12 months 5. Incidence and severity of suicidal behaviour and self-harm using the Deliberate Self-Harm Inventory at baseline, 6 and 12 months 6. Self-Reported Version of ZAN BPD at baseline, 3, 6, 9 and 12 months 7. Social functioning measured via the Work and Social Adjustment Scale (WSAS) at baseline, 6 and 12 months 8. Health-related quality of life measured using EuroQoL-5D-5L at baseline, 6 and 12 months 9. Side effects using the Antipsychotic Non-Neurological Side Effects Scale (ANNSERS) at baseline, 3, 6, 9 and 12 months 10. Medication adherence using the Brief Adherence Rating Scale (BARS) at 3, 6, 9 and 12 months 11. Use of alcohol and other drugs via ASSIST-Lite at baseline, 6 and 12 months 12. Body Weight in Kg at baseline and 12 months 13. Serious adverse events up to 12 months 14. Use of rescue medication at 6 and 12 months 15. Sleep Disturbance using PROMIS Sleep Disturbance -Short Form at baseline, 3, 6, 9 and 12 months 16. Use of health and social services using the ADSUS at baseline, 6 and 12 months |
| Overall study start date | 03/03/2025 |
| Overall study end date | 31/10/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 270 |
| Participant inclusion criteria | 1. Aged ≥18 years 2. Able to provide written and informed consent and agreement to comply with the requirements of the trial. 3. In contact with secondary care mental health services. 4. Meet diagnostic criteria for borderline personality disorder using the Structured Clinical Interview for DSM-V Personality Disorders (SCID 5). 5. A ZAN-BPD total score of ≥9 at the time of randomisation. 6. Ability to speak and read English 7. Able to swallow IMP whole |
| Participant exclusion criteria | 1. Prescribed an antipsychotic medication within 2 weeks of baseline assessments. 2. Have a current clinical diagnosis of schizophrenia, bipolar I or bipolar II disorder. 3. Pregnant, trying to conceive and/or breastfeeding. 4. Women of childbearing potential who are unable or unwilling to use a highly effective method of contraception for the duration of the trial. 5. Known hypersensitivity to quetiapine or to any of the excipients of the XL formulation. 6. Concomitant administration of erythromycin, clarithromycin or nefazodone within 14 days. 7. Concomitant administration of cytochrome P450 3A4 inhibitors, such as anti-fungal medicines: (itraconozole, ketoconazole, voriconazole, posaconazole); medicines used to treat cancer: idelalisib, tucatinib, ceritinib; medicines used to treat HIV; atazanavir, cobicistat, darunavir, fosamprenavir, lopinavir, ritonavir, saquinavir, tipanavir. 8. History of QTc prolongation, severe neutropenia, agranulocytosis, history of cardiovascular disease (angina, stroke, myocardial infarction, arrhythmia, congestive cardiac failure) |
| Recruitment start date | 31/05/2025 |
| Recruitment end date | 31/07/2027 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Kings Business Park
Kings Drive
Prescot
L34 1PJ
United Kingdom
Fulbourn Hospital
Fulbourn
Cambridge
CB21 5EF
United Kingdom
52 Queensbridge Road
Moseley
Birmingham
B13 8QY
United Kingdom
Sponsor information
University/education
Liverpool Clinical Trials Centre
Liverpool
L69 3GL
England
United Kingdom
| questtrial@liverpool.ac.uk | |
| Website | http://www.liv.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Peer reviewed scientific journals Conference presentation Publication on website Submission to regulatory authorities Registration on a public database. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Editorial Notes
05/03/2025: Trial's existence confirmed by NHS HRA.
