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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01133301
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : May 28, 2010
Sponsor:
Collaborator:
University of Freiburg
Information provided by:
Central Institute of Mental Health, Mannheim

Tracking Information
First Submitted Date  ICMJE May 17, 2010
First Posted Date  ICMJE May 28, 2010
Last Update Posted Date May 28, 2010
Study Start Date  ICMJE August 1998
Actual Primary Completion Date August 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder
Official Title  ICMJE Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Borderline Personality Disorder
  • Dissociation
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Naltrexone
    • Drug: Placebo
  • Placebo Comparator: Placebo-Naltrexone
    The first three weeks, placebo will be administrated, the following three weeks 50 mg Naltrexone will be administrated.
    Interventions:
    • Drug: Naltrexone
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2010)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2001
Actual Primary Completion Date August 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01133301
Other Study ID Numbers  ICMJE Naltrexone-BPD
nal-diss-bpd ( Other Identifier: Intern )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Central Institute of Mental Health, Mannheim
Collaborators  ICMJE University of Freiburg
Investigators  ICMJE
Study Chair: Christian Schmahl, MD Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine
PRS Account Central Institute of Mental Health, Mannheim
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP