Status:
TERMINATED
Naltrexone in Borderline Personality Disorder
Lead Sponsor:
Central Institute of Mental Health, Mannheim
Conditions:
Borderline Personality Disorder
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00124839
Start Date
October 1 2005
End Date
March 1 2008
Last Update
April 15 2008
Active Locations (5)
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1
Dept. of Psychosomatic Medicine, Central Instiute of Mental Health
Mannheim, Baden-Würtemberg, Germany, 68159
2
Klinik Dr. Schlemmer GmbH, Center for Psychosomatic Medicine
Bad Wiessee, Bavaria, Germany, 83707
3
Inntalklinik Simbach am Inn
Simbach, Bavaria, Germany, 84359
4
Dept.of Psychiatry and Psychotherapy; Center of Neurology
Rostock, Mecklenburg-Vorpommern, Germany, 18147