None listed
Conditions
Brief summary
To date, no drugs are approved for the treatment of borderline personality disorder (BPD). Newly published evidence showing that the antipsychotic drug, quetiapine, improves BPD symptoms suggests that quetiapine might facilitate the benefits of psychotherapy – currently the only evidence-based treatment for BPD. We plan to investigate this at Spectrum (Eastern Health), the specialist service for treatment of BPD in Victoria, Australia
Interventions
The utility of quetiapine (25 - 200mg/day, oral) will be assessed in patients diagnosed with severe borderline personality disorder. Patients who have given informed consent will be randomly assigned to receive placebo or quetiapine in a double-blind study. Dose will be adjusted weekly in 25 mg/day increments depending on efficacy and tolerability. After 12 weeks, participants will commence evidence-based weekly individual in combination with group psychotherapy (assignment to Dialectical Beh
The utility of quetiapine (25 - 200mg/day, oral) will be assessed in patients diagnosed with severe borderline personality disorder. Patients who have given informed consent will be randomly assigned to receive placebo or quetiapine in a double-blind study. Dose will be adjusted weekly in 25 mg/day increments depending on efficacy and tolerability. After 12 weeks, participants will commence evidence-based weekly individual in combination with group psychotherapy (assignment to Dialectical Behavior Therapy or Mentalisation Based Therapy by clinician discretion) while continuing on quetiapine or placebo treatment. Weekly psychotherapy will comprise a 1 h individual session and a 1-2 h group session administered by a mental health clinician. Safety and efficacy will be assessed at frequent intervals with the blinded study ending after 12 months of psychotherapy (15 months after commencing drug or placebo treatment). Quetiapine or placebo medication will be dispensed weekly for up to 15 months (the end point of the study). Participants will bring the package from the medication that was dispensed the previous week to their weekly appointment to monitor adherence. The provision of psychotherapy is expected to assist in participant retention. Medical examination, questionnaires and blood tests will be used to monitor safety.
Sponsors
Eastern Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Age 18-65; Primary diagnosis of borderline personality disorder; Negative pregnancy test if of child-bearing age; Not currently dependent on alcohol or illicit drugs; Normal pre-study laboratory values.
Exclusion criteria
Lifetime diagnosis of schizophrenia or schizoaffective disorder according to DSM-5; Lifetime diagnosis of bipolar disorder according to DSM-5; Current severe major depressive episode according to DSM-5; Current severe somatic illness; Current substance abuse disorder (quetiapine has abuse potential); Current psychotic disorder due to either substance use disorder or a general medical condition; Use of drugs that induce or inhibit the metabolising cytochrome 3A4 enzymes within two weeks prior to week zero and during the course of the study; Previous prescription of quetiapine; Contraindication for antipsychotics; Pregnant or lactating; if of child-bearing age, not taking appropriate contraceptive precautions.
Outcome results
None listed