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Naltrexone in Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Naltrexone
Sponsored by
Central Institute of Mental Health, Mannheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Dissociation, Flashbacks, Self-injurious behavior

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Psychosomatic Medicine, Central Instiute of Mental Health
  • Klinik Dr. Schlemmer GmbH, Center for Psychosomatic Medicine
  • Inntalklinik Simbach am Inn
  • Dept.of Psychiatry and Psychotherapy; Center of Neurology
  • Dept.of Psychiatry and Psychotherapy , Rheinische Kliniken Köln

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

1

2

3

4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Reduction of dissociative symptoms

Secondary Outcome Measures

Reduction of flashbacks
Reduction of self-injurious behavior
Reduction of psychopathology (depression, anxiety, anger, borderline symptoms)
Safety regarding liver enzyme elevation

Full Information

First Posted
July 27, 2005
Last Updated
April 14, 2008
Sponsor
Central Institute of Mental Health, Mannheim
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1. Study Identification

Unique Protocol Identification Number
NCT00124839
Brief Title
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

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in recruiting enough subjects
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Central Institute of Mental Health, Mannheim

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Dissociation, Flashbacks, Self-injurious behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Blinded sequential administration: naltrexon 50 mg (3 weeks)- placebo (3 weeks)- placebo (1 week)
Arm Title
2
Arm Type
Other
Arm Description
Blinded sequential administration: 200mg naltrexone (3 weeks) - placebo (3 weeks)- placebo (1 week)
Arm Title
3
Arm Type
Other
Arm Description
Blinded sequential administration: placebo (3 weeks) - 200mg naltrexone (3 weeks) - placebo (1 week)
Arm Title
4
Arm Type
Other
Arm Description
Blinded sequential administration: placebo (3 weeks) - 50mg naltrexone (3 weeks) - placebo (1 week)
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
Daily oral administration (capsules): 50mg naltrexone and placebo or 200mg naltrexone and placebo or placebo and naltrexon 50mg or placebo and 200mg naltrexone
Primary Outcome Measure Information:
Title
Reduction of dissociative symptoms
Time Frame
End of 3rd week treatment of naltrexon
Secondary Outcome Measure Information:
Title
Reduction of flashbacks
Time Frame
End of 3rd week treatment of naltrexone
Title
Reduction of self-injurious behavior
Time Frame
End of 3rd week treatment of naltrexone
Title
Reduction of psychopathology (depression, anxiety, anger, borderline symptoms)
Time Frame
End of 3rd week treatment of naltrexone
Title
Safety regarding liver enzyme elevation
Time Frame
End of 3rd week treatment of naltrexone

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Bohus, M.D.
Organizational Affiliation
University of Heidelberg, Central Institute of Mental Health Mannheim
Official's Role
Study Director
Facility Information:
Facility Name
Dept. of Psychosomatic Medicine, Central Instiute of Mental Health
City
Mannheim
State/Province
Baden-Würtemberg
ZIP/Postal Code
68159
Country
Germany
Facility Name
Klinik Dr. Schlemmer GmbH, Center for Psychosomatic Medicine
City
Bad Wiessee
State/Province
Bavaria
ZIP/Postal Code
83707
Country
Germany
Facility Name
Inntalklinik Simbach am Inn
City
Simbach
State/Province
Bavaria
ZIP/Postal Code
84359
Country
Germany
Facility Name
Dept.of Psychiatry and Psychotherapy; Center of Neurology
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18147
Country
Germany
Facility Name
Dept.of Psychiatry and Psychotherapy , Rheinische Kliniken Köln
City
Cologne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51109
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
10846724
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.
Results Reference
background
PubMed Identifier
10520978
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.
Results Reference
background
PubMed Identifier
10231814
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.
Results Reference
background
PubMed Identifier
36375174
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.
Results Reference
derived

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Naltrexone in Borderline Personality Disorder

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