Naltrexone in Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00124839
• Other study ID #: Naltrexon-BPS
• Status: Terminated
• Phase: Phase 3
• First received: July 27, 2005
• Last updated: April 14, 2008
• Start date: October 2005
• Est. completion date: March 2008

Study information

• Verified date: April 2008
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: March 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Drug:
• Naltrexone
Daily oral administration (capsules): 50mg naltrexone and placebo or 200mg naltrexone and placebo or placebo and naltrexon 50mg or placebo and 200mg naltrexone

Locations

Country	Name	City	State
Germany	Klinik Dr. Schlemmer GmbH, Center for Psychosomatic Medicine	Bad Wiessee	Bavaria
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	Dept.of Psychiatry and Psychotherapy; Center of Neurology	Rostock	Mecklenburg-Vorpommern
Germany	Inntalklinik Simbach am Inn	Simbach	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Bohus MJ, Landwehrmeyer GB, Stiglmayr CE, Limberger MF, Böhme 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. — View Citation

Schmahl C, Bohus M. [Treatment of dissociative symptoms in borderline personality disorder with naltrexone: supplementary comments]. Nervenarzt. 2000 May;71(5):427. German. — View Citation

Schmahl C, Stiglmayr C, Böhme R, Bohus M. [Treatment of dissociative symptoms in borderline patients with naltrexone]. Nervenarzt. 1999 Mar;70(3):262-4. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of dissociative symptoms		End of 3rd week treatment of naltrexon
Secondary	Reduction of flashbacks		End of 3rd week treatment of naltrexone
Secondary	Reduction of self-injurious behavior		End of 3rd week treatment of naltrexone
Secondary	Reduction of psychopathology (depression, anxiety, anger, borderline symptoms)		End of 3rd week treatment of naltrexone
Secondary	Safety regarding liver enzyme elevation		End of 3rd week treatment of naltrexone