Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder - Full Text View

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:

MedlinePlus related topics: Personality Disorders

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

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

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 June 18, 2013