Naltrexone in Borderline Personality Disorder

This study has been terminated.
(Difficulties in recruiting enough subjects)
Sponsor:
Information provided by:
Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:
NCT00124839
First received: July 27, 2005
Last updated: April 14, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Borderline Personality Disorder
Drug: Naltrexone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Central Institute of Mental Health, Mannheim:

Primary Outcome Measures:
  • Reduction of dissociative symptoms [ Time Frame: End of 3rd week treatment of naltrexon ]

Secondary Outcome Measures:
  • Reduction of flashbacks [ Time Frame: End of 3rd week treatment of naltrexone ]
  • Reduction of self-injurious behavior [ Time Frame: End of 3rd week treatment of naltrexone ]
  • Reduction of psychopathology (depression, anxiety, anger, borderline symptoms) [ Time Frame: End of 3rd week treatment of naltrexone ]
  • Safety regarding liver enzyme elevation [ Time Frame: End of 3rd week treatment of naltrexone ]

Estimated Enrollment: 48
Study Start Date: October 2005
Study Completion Date: March 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Blinded sequential administration: naltrexon 50 mg (3 weeks)- placebo (3 weeks)- placebo (1 week)
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
2
Blinded sequential administration: 200mg naltrexone (3 weeks) - placebo (3 weeks)- placebo (1 week)
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
3
Blinded sequential administration: placebo (3 weeks) - 200mg naltrexone (3 weeks) - placebo (1 week)
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
4
Blinded sequential administration: placebo (3 weeks) - 50mg naltrexone (3 weeks) - placebo (1 week)
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124839

Locations
Germany
Dept. of Psychosomatic Medicine, Central Instiute of Mental Health
Mannheim, Baden-Würtemberg, Germany, 68159
Klinik Dr. Schlemmer GmbH, Center for Psychosomatic Medicine
Bad Wiessee, Bavaria, Germany, 83707
Inntalklinik Simbach am Inn
Simbach, Bavaria, Germany, 84359
Dept.of Psychiatry and Psychotherapy; Center of Neurology
Rostock, Mecklenburg-Vorpommern, Germany, 18147
Dept.of Psychiatry and Psychotherapy , Rheinische Kliniken Köln
Cologne, Nordrhein-Westfalen, Germany, 51109
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
Investigators
Study Director: Martin Bohus, M.D. University of Heidelberg, Central Institute of Mental Health Mannheim
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00124839     History of Changes
Other Study ID Numbers: Naltrexon-BPS
Study First Received: July 27, 2005
Last Updated: April 14, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Central Institute of Mental Health, Mannheim:
Dissociation
Flashbacks
Self-injurious behavior

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014