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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Borderline Personality Disorder, Dissociation

Intervention / Treatment
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* Drug: Naltrexone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naltrexone-Placebo<br>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<br>* 50 mg/d Naltrexone will be administrated during three weeks.<br>Drug: Placebo<br>* During 3 weeks of the study, Placebo will be administrated (daily)<br>|
| Placebo Comparator: Placebo-Naltrexone<br>The first three weeks, placebo will be administrated, the following three weeks 50 mg Naltrexone will be administrated. | Drug: Naltrexone<br>* 50 mg/d Naltrexone will be administrated during three weeks.<br>Drug: Placebo<br>* During 3 weeks of the study, Placebo will be administrated (daily)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) |  | Oct. 1998-Oct 2001 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Borderline Personality Disorder, Dissociation, Naltrexone