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Completed

NCT Number: NCT01133301

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry and Psychotherapy, University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naltrexone

Drug

50 mg/d Naltrexone will be administrated during three weeks.

Placebo

Drug

During 3 weeks of the study, Placebo will be administrated (daily)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Number and intensity of flashbacks during the last week.

    The number and intensity of flashbacks are documented at the end of each week

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Collaborators

  • University of Freiburg

Registry information

Important dates

Study start
1998
Primary completion
2001
Study completion
2001
First posted
May 28, 2010
Registry last updated
May 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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