Clinical trial NCT00124839: Naltrexone in Borderline Personality Disorder
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Borderline Personality Disorder
Keywords: Dissociation
Flashbacks
Self-injurious behavior
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2005-07-28
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Reduction of dissociative symptoms
timeFrame: End of 3rd week treatment of naltrexon
Secondary outcomes:
measure: Reduction of flashbacks
timeFrame: End of 3rd week treatment of naltrexone
measure: Reduction of self-injurious behavior
timeFrame: End of 3rd week treatment of naltrexone
measure: Reduction of psychopathology (depression, anxiety, anger, borderline symptoms)
timeFrame: End of 3rd week treatment of naltrexone
measure: Safety regarding liver enzyme elevation
timeFrame: End of 3rd week treatment of naltrexone
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Dept. of Psychosomatic Medicine, Central Instiute of Mental Health
state: Baden-Würtemberg
city: Bad Wiessee
country: Germany
facility: Klinik Dr. Schlemmer GmbH, Center for Psychosomatic Medicine
state: Bavaria
city: Simbach
country: Germany
facility: Inntalklinik Simbach am Inn
state: Bavaria
city: Rostock
country: Germany
facility: Dept.of Psychiatry and Psychotherapy; Center of Neurology
state: Mecklenburg-Vorpommern
city: Cologne
country: Germany
facility: Dept.of Psychiatry and Psychotherapy , Rheinische Kliniken Köln
state: Nordrhein-Westfalen
Study officials:
affiliation: University of Heidelberg, Central Institute of Mental Health Mannheim
name: Martin Bohus, M.D.
role: STUDY_DIRECTOR
References:
citation: Schmahl C, Bohus M. [Treatment of dissociative symptoms in borderline personality disorder with naltrexone: supplementary comments]. Nervenarzt. 2000 May;71(5):427. doi: 10.1007/s001150050582. No abstract available. German.
citation: 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. doi: 10.4088/jcp.v60n0906.
citation: Schmahl C, Stiglmayr C, Bohme R, Bohus M. [Treatment of dissociative symptoms in borderline patients with naltrexone]. Nervenarzt. 1999 Mar;70(3):262-4. doi: 10.1007/s001150050431. German.
citation: Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.