Naltrexone in Borderline Personality Disorder

NCT00124839 | Terminated Phase 3

• 1 other identifier: Naltrexon-BPS
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

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.

Conditions

Borderline Personality Disorder

Keywords

Dissociation; Flashbacks; Self-injurious behavior

Outcome Measures

Primary Outcomes (1)

• Reduction of dissociative symptoms

  End of 3rd week treatment of naltrexon

Secondary Outcomes (4)

• Reduction of flashbacks

  End of 3rd week treatment of naltrexone

• Reduction of self-injurious behavior

  End of 3rd week treatment of naltrexone

• Reduction of psychopathology (depression, anxiety, anger, borderline symptoms)

  End of 3rd week treatment of naltrexone

• Safety regarding liver enzyme elevation

  End of 3rd week treatment of naltrexone

Study Arms (4)

1

OTHER

Blinded sequential administration: naltrexon 50 mg (3 weeks)- placebo (3 weeks)- placebo (1 week)

Drug: Naltrexone

2

OTHER

Blinded sequential administration: 200mg naltrexone (3 weeks) - placebo (3 weeks)- placebo (1 week)

Drug: Naltrexone

3

OTHER

Blinded sequential administration: placebo (3 weeks) - 200mg naltrexone (3 weeks) - placebo (1 week)

Drug: Naltrexone

4

OTHER

Blinded sequential administration: placebo (3 weeks) - 50mg naltrexone (3 weeks) - placebo (1 week)

Drug: Naltrexone

Interventions

Naltrexone DRUG

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

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (5)

Dept. of Psychosomatic Medicine, Central Instiute of Mental Health

Mannheim, Baden-Würtemberg, 68159, Germany

Location

Klinik Dr. Schlemmer GmbH, Center for Psychosomatic Medicine

Bad Wiessee, Bavaria, 83707, Germany

Location

Inntalklinik Simbach am Inn

Simbach, Bavaria, 84359, Germany

Location

Dept.of Psychiatry and Psychotherapy; Center of Neurology

Rostock, Mecklenburg-Vorpommern, 18147, Germany

Location

Dept.of Psychiatry and Psychotherapy , Rheinische Kliniken Köln

Cologne, North Rhine-Westphalia, 51109, Germany

Location

Related Publications (4)

• 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.

  PMID: 10846724 BACKGROUND

• 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.

  PMID: 10520978 BACKGROUND

• 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.

  PMID: 10231814 BACKGROUND

• 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.

  PMID: 36375174 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder; Dissociative Disorders; Self-Injurious Behavior

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Martin Bohus, M.D.

  University of Heidelberg, Central Institute of Mental Health Mannheim

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2005
• First Posted: July 28, 2005
• Study Start: October 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: March 1, 2008
• Last Updated: April 15, 2008

Record last verified: 2008-04

Locations

DE (5)