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Clinical Trial: Naltrexone in Borderline Personality Disorder
This study is not yet open for patient recruitment.
Verified by University of Heidelberg July 2005
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Borderline Personality Disorder | Drug: Naltrexone | Phase III |
MedlinePlus related topics: Personality Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Evaluation of the Efficacy of the Opioid Antagonist Naltrexone on the Incidence and Intensity of Flashbacks and Dissociative States in Patients with Borderline Personality Disorder
Secondary Outcomes: Reduction of flashbacks; Reduction of self-injurious behavior; Reduction of psychopathology Depression, anxiety, anger, Borderline symptoms); Safety regarding liver enzyme elevation
Expected Total Enrollment: 48
Study start: September 2005; Expected completion: June 2008
Last follow-up: September 2007; Data entry closure: December 2007
Eligibility
Inclusion Criteria:
- Borderline Personality Disorder acc. to DSM IV
- DES-(Dissociative Experience Scale)-score > 25
- No psychopharmacological treatment for tow weeks prior to study (Fluoxetine four weeks)
- No Lithium fot two months
Exclusion Criteria:
- Lifetime diagnosis of psychotic disorder
- Current 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
Location and Contact Information
Angela Buenger, B.A. +49-621-1703-4406 buenger@zi-mannheim.de
Germany
Dept. of Psychosomatic Medicine, Central Instiute of Mental Health, Mannheim, 68159, Germany
Dept. of Psychiatry, University of Freiburg, Freiburg, 79104, Germany
Dept. of Psychiatry, University of Duesseldorf, Duesseldorf, 40629, Germany
Klinik Dr. Schlemmer GmbH, Center for Psychosomatic Medicine, Bad Wiessee, 83707, Germany
Martin Bohus, M.D., Principal Investigator, University of Heidelberg, Central Institute of Mental Health Mannheim
More Information
Publications
Schmahl C, Bohus M. [Treatment of dissociative symptoms in borderline personality disorder with naltrexone: supplementary comments] Nervenarzt. 2000 May;71(5):427. German. No abstract available.
Bohus MJ, Landwehrmeyer GB, Stiglmayr CE, Limberger MF, Bohme R, Schmahl CG. Naltrexone in the treatment of dissociative symptoms in patients with borderline personality disorder: an open-label trial. J Clin Psychiatry. 1999 Sep;60(9):598-603.
Schmahl C, Stiglmayr C, Bohme R, Bohus M. [Treatment of dissociative symptoms in borderline patients with naltrexone] Nervenarzt. 1999 Mar;70(3):262-4. German.
Last Updated: August 1, 2005
Record first received: July 27, 2005
ClinicalTrials.gov Identifier: NCT00124839
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-08-02
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