Naltrexone in Borderline Personality Disorder
- Registration Number
- NCT00124839
- Lead Sponsor
- Central Institute of Mental Health, Mannheim
- Brief Summary
The purpose of this study is to investigate whether naltrexone reduces the intensity and duration of flashbacks and dissociative states in patients with borderline personality disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 48
Inclusion Criteria
- In- and Outpatients:Borderline personality disorder according to the Diagnostic and Statistical Manual for Mental Disorders, 4.Edition (DSM IV)
- DES-(Dissociative Experience Scale)-score: > or equal 18 according to amendment4 (former value according to amendment 2 was > or equal 25).
- Urinary test of opiates negative
- No psychopharmacological treatment for two weeks prior to study (fluoxetine four weeks)
- No Lithium for two months
Exclusion Criteria
- Lifetime diagnosis of psychotic disorder
- Current major depressive disorder (MDD)
- Lifetime diagnosis opioid dependence or current opioid abuse (10 to 7 days prior to study)
- Comedication with opioid analgetics
- Known naltrexone intolerance
- Liver disease
- Pregnancy and lactation period
- Other severe medical or neurological diseases
- Simultaneous participation in another study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 4 Naltrexone Blinded sequential administration: placebo (3 weeks) - 50mg naltrexone (3 weeks) - placebo (1 week) 1 Naltrexone Blinded sequential administration: naltrexon 50 mg (3 weeks)- placebo (3 weeks)- placebo (1 week) 3 Naltrexone Blinded sequential administration: placebo (3 weeks) - 200mg naltrexone (3 weeks) - placebo (1 week) 2 Naltrexone Blinded sequential administration: 200mg naltrexone (3 weeks) - placebo (3 weeks)- placebo (1 week)
- Primary Outcome Measures
Name Time Method Reduction of dissociative symptoms End of 3rd week treatment of naltrexon
- Secondary Outcome Measures
Name Time Method Reduction of flashbacks End of 3rd week treatment of naltrexone Reduction of self-injurious behavior End of 3rd week treatment of naltrexone Reduction of psychopathology (depression, anxiety, anger, borderline symptoms) End of 3rd week treatment of naltrexone Safety regarding liver enzyme elevation End of 3rd week treatment of naltrexone
Trial Locations
- Locations (5)
Klinik Dr. Schlemmer GmbH, Center for Psychosomatic Medicine
🇩🇪Bad Wiessee, Bavaria, Germany
Inntalklinik Simbach am Inn
🇩🇪Simbach, Bavaria, Germany
Dept.of Psychiatry and Psychotherapy; Center of Neurology
🇩🇪Rostock, Mecklenburg-Vorpommern, Germany
Dept.of Psychiatry and Psychotherapy , Rheinische Kliniken Köln
🇩🇪Cologne, Nordrhein-Westfalen, Germany
Dept. of Psychosomatic Medicine, Central Instiute of Mental Health
🇩🇪Mannheim, Baden-Würtemberg, Germany