A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder
Summary
There are currently no pharmacological treatments approved to treat borderline personality disorder (BPD). This trial will be conducted to evaluate the efficacy and safety of brexpiprazole for the treatment of participants diagnosed with BPD to provide a pharmacological treatment for BPD.
Timeline
- Start
- 2019-10-17
- Primary completion
- 2021-06-27
- Completion
- 2021-06-27
Outcome
Missed primary endpoint
registry analysis (superiority test); Brexpiprazole 2-3 Milligrams Per Day vs Placebo; p = 0.2430; Least Square (LS) Mean Difference -1.02 (95% CI -2.75 to 0.70); NCT04100096 ↗
paper Brexpiprazole was not statistically significantly different from placebo on the primary endpoint of the randomised study (N = 324 randomised; N = 110 analysed per treatment group; least squares mean difference -1.02; 95% confidence limits -2.75, 0.70; p = 0.24). PMID 39558901 ↗
paper CONCLUSION: The primary endpoint of the randomised study was not met. PMID 39558901 ↗
Publications
- Rothman B, Brewer C, Chang D, Hobart M, Hefting N, McQuade RD, Grant JE. A randomised study and an extension study of brexpiprazole in patients with borderline personality disorder. Acta Neuropsychiatr. 2024 Nov 19;37:e39. doi: 10.1017/neu.2024.31.
- Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brexpiprazole | Small molecule | 2 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 3 mg | Oral |