Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder

This study has been completed.
Sponsor:
Collaborator:
University of Freiburg
Information provided by:
Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:
NCT01133301
First received: May 17, 2010
Last updated: May 26, 2010
Last verified: May 2010
  Purpose

Our study aims at contributing to a valid appraisal of the magnitude of naltrexone efficacy as an antidissociative agent by using a double-blind randomized controlled trial.


Condition Intervention Phase
Borderline Personality Disorder
Dissociation
Drug: Naltrexone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Naltrexone in the Treatment of Dissociative Symptoms 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:
  • Dissociation Tension Scale (DSS), a reliable and valid self-rating instrument to assess dissociative experiences and inner tension during the last 24 hours (Stiglmayr et al. 2001) [ Time Frame: Oct. 1998-Oct 2001 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number, the method, and the severity of non-suicidal self-injurious acts during the last week. [ Designated as safety issue: No ]
    The number, method and the severity of non-suicidal self-injurious acts are documented at the end of each week.

  • Number and intensity of flashbacks during the last week. [ Designated as safety issue: No ]
    The number and intensity of flashbacks are documented at the end of each week


Enrollment: 30
Study Start Date: August 1998
Study Completion Date: October 2001
Primary Completion Date: August 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Naltrexone-Placebo
In the first three weeks of the study, 50 mg Naltrexone will be administrated, the following three three weeks placebo will be administrated.
Drug: Naltrexone
50 mg/d Naltrexone will be administrated during three weeks.
Drug: Placebo
During 3 weeks of the study, Placebo will be administrated (daily)
Placebo Comparator: Placebo-Naltrexone
The first three weeks, placebo will be administrated, the following three weeks 50 mg Naltrexone will be administrated.
Drug: Naltrexone
50 mg/d Naltrexone will be administrated during three weeks.
Drug: Placebo
During 3 weeks of the study, Placebo will be administrated (daily)

Detailed Description:

Patients were randomized into two groups starting with either 3 weeks of 50 mg/d naltrexone or with 3 weeks of placebo. In either case the active treatment phases (weeks 1-6) were followed by one week of placebo. The major purpose of weeks 1-2 and 4-5, respectively, was to achieve a steady state during the active treatment. The primary comparisons of psychopathology under naltrexone and placebo refer to the weeks following the intended achievement of a steady state (weeks 3 and 6, respectively).

6 weeks of treatment were split into two phases: (A) 3 weeks of pharmacologically active treatment with naltrexone and (B) 3 weeks of pharmacologically inactive treatment with placebo (cross-over design). The sequence of the two treatment phases was randomized and concealed from both the patients and the health care professionals. In both cases, the last week ("Week 7") was without pharmacological intervention.

The primary outcome was based on the DSS, a reliable and valid self-rating instrument to assess dissociative experiences and inner tension during the last 24 hours (Stiglmayr et al. 2001) Mean scores for intensity (ranging from 0="no" to 9="very strong") and for duration (average time during which a particular symptom was present during the last 24 hours (in %)) were calculated for (a) dissociation (calculated from 21 Likert type items) and of (b) aversive inner tension (one item).

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of BPD according to DSM-IV
  • DES score ≥ 18
  • Female gender
  • Age between 18 and 50 years

Exclusion Criteria:

  • Lifetime diagnosis of schizophrenia, psychotic or delusional disorder
  • Current major depressive episode
  • Lifetime diagnosis opioid dependence
  • Current diagnosis opioid abuse
  • Liver insufficiency or hepatitis
  • Other major medical or neurological medical condition
  • Pregnancy or lactation
  • Psychotropic medication within two weeks before and during the trial (fluoxetine 4 weeks, lithium 8 weeks)
  • Concomitant treatment with opioid analgetics
  • Hypersensitivity to naltrexone
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133301

Locations
Germany
Department of Psychiatry and Psychotherapy, University of Freiburg
Freiburg, Baden Württemberg, Germany, 79104
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
University of Freiburg
Investigators
Study Chair: Christian Schmahl, MD Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01133301     History of Changes
Other Study ID Numbers: Naltrexone-BPD, nal-diss-bpd
Study First Received: May 17, 2010
Last Updated: May 26, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Central Institute of Mental Health, Mannheim:
Borderline Personality Disorder
Dissociation
Naltrexone

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Dissociative Disorders
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 July 20, 2014