None listed
Conditions
Brief summary
To date, only one open label trial on asenapine in the treatment of borderline personality disorder (BPD) is available. This study is aimed to test the efficacy and tolerability of asenapine compared with olanzapine (a widely studied antipsychotic in treatment of BPD). We will recruit consecutive patients with diagnosis of BPD. Patients will be randomly assigned to two arms of treatment: (1) asenapine (5-10 mg(day) or (2) olanzapine (5-10 mg/day). The trial duration will be 12 weeks. All participants will be tested at baseline, and after 6 and 12 weeks with the following instruments: the Clinical Global Impression Scale (CGI-S); the Borderline Personality Disorder Severity Index (BPDSI); the Barratt Impulsiveness Scale - version 11 (BIS-11); the Modified Overt Aggression Scale (MOAS); the Self-Harm Inventory (SHI); the Social and Occupational Functioning Assessment Scale (SOFAS); and the Dosage Record and Treatment Emergent Symptom Scale (DOTES).
Interventions
Patients will be randomly assigned to two arms of treatment: 1) asenapine (dose range: 5-10 mg/day) or 2) olanzapine (dose range: 5-10 mg/day). All drugs will be administered daily as oral tablets. The two drugs will be titrated (for the first three days at the dose of 5 mg/day and after at the dose if 10 mg/day, if side effects do not appear). The duration of treatment will be 12 weeks.
To monitor compliance to therapy we will check drug tablet return and we will ask, when available, the cooper
Patients will be randomly assigned to two arms of treatment: 1) asenapine (dose range: 5-10 mg/day) or 2) olanzapine (dose range: 5-10 mg/day). All drugs will be administered daily as oral tablets. The two drugs will be titrated (for the first three days at the dose of 5 mg/day and after at the dose if 10 mg/day, if side effects do not appear). The duration of treatment will be 12 weeks. To monitor compliance to therapy we will check drug tablet return and we will ask, when available, the cooperation of a caregiver.
Sponsors
Centre for Personality Disorders, Psychiatric Clinic, Department of Neuroscience, University of Turin, Italy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of borderline personality disorder
Exclusion criteria
Dementia, delirium and other cognitive disorders; schizophrenia and other psychotic disorders. Lifetime bipolar disorders. Concurrent major depressive episode. Substance abuse in the last two months.
Outcome results
None listed