Naltrexone in Borderline Personality Disorder - Full Text View

Sponsored by:	Central Institute of Mental Health, Mannheim
Information provided by:	Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:	NCT00124839

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 III

MedlinePlus related topics: Mental Health Personality Disorders

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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

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, Baden-Würtemberg
Dept. of Psychosomatic Medicine, Central Instiute of Mental Health
Mannheim, Baden-Würtemberg, Germany, 68159
Germany, Bavaria
Klinik Dr. Schlemmer GmbH, Center for Psychosomatic Medicine
Bad Wiessee, Bavaria, Germany, 83707
Inntalklinik Simbach am Inn
Simbach, Bavaria, Germany, 84359
Germany, Mecklenburg-Vorpommern
Dept.of Psychiatry and Psychotherapy; Center of Neurology
Rostock, Mecklenburg-Vorpommern, Germany, 18147
Germany, Nordrhein-Westfalen
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:

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.

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

Keywords provided by Central Institute of Mental Health, Mannheim:

Dissociation
Flashbacks
Self-injurious behavior

Study placed in the following topic categories:

Mental Disorders
Naltrexone
Borderline Personality Disorder
Self-Injurious Behavior
Personality Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs

Narcotic Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009