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

May 26, 2010 updated by: Central Institute of Mental Health, Mannheim
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden Württemberg
      • Freiburg, Baden Württemberg, Germany, 79104
        • Department of Psychiatry and Psychotherapy, University of Freiburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Oct. 1998-Oct 2001

Secondary Outcome Measures

Outcome Measure
Measure Description
The number, the method, and the severity of non-suicidal self-injurious acts during the last week.
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.
The number and intensity of flashbacks are documented at the end of each week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Mental Health, Mannheim

Collaborators

University of Freiburg

Investigators

  • Study Chair: Christian Schmahl, MD, Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Primary Completion (Actual)

August 1, 2001

Study Completion (Actual)

October 1, 2001

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (Estimate)

May 28, 2010

Study Record Updates

Last Update Posted (Estimate)

May 28, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Naltrexone-BPD
  • nal-diss-bpd (Other Identifier: Intern)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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