Borderline personality disorder Mental and Behavioural Disorders
Conditions
Interventions
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 administrat
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 03/10/2025: 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. Contraception is to be used for the duration of the trial 5. Meet diagnostic criteria for borderline personality disorder using the Structured Clinical Interview for DSM-V Personality Disorders (SCID-5) 6. A ZAN-BPD total score of =9 at the time of randomisation 7. Ability to speak and read English Previous key 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
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 21/01/2026: 1. Prescribed an antipsychotic medication (oral or intramuscular) within two 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: (itraconazole, ketoconazole, voriconazole, posaconazole); medicines used to treat cancer: idelalisib, tucatinib, ceritinib; medicines used to treat HIV: atazanavir, cobicistat, darunavir, fosamprenavir, lopinavir, ritonavir, saquinavir, tipranavir 8. History of QTc prolongation, including congenital long QT syndrome, severe neutropenia, agranulocytosis, history of cardiovascular disease (angina, stroke, myocardial infarction, arrythmia, congestive cardiac failure, heart hypertrophy) 9. Unable/refusal to undertake blood tests 10. Clinically significant findings that, in the opinion of the investigator, are contraindicated for inclusion in the study 11. Unable to swallow IMP whole 12. Individuals who are being investigated for or have a confirmed diagnosis of dementia (any kind) Previous exclusion criteria as of 03/10/2025: 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: (itraconazole, ketoconazole, voriconazole, posaconazole); medicines used to treat cancer: idelalisib, tucatinib, ceritinib; medicines used to treat HIV: atazanavir, cobicistat, darunavir, fosamprenavir, lopinavir, ritonavir, saquinavir, tipranavir 8. History of QTc prolongation, severe neutropenia, agranulocytosis, history of cardiovascular disease (angina, stroke, myocardial infarction, arrhythmia, congestive cardiac failure) 9. Unable/refusal to undertake blood tests 10. Clinically significant findings that, in the opinion of the investigator, are contraindicated for inclusion in the study 11. Unable to swallow IMP whole Previous key 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 me
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Symptoms of BPD at 12 months using the total score on the ZAN BPD from baseline to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactNadia Ismail
Outcome results
None listed