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

Central Institute of Mental Health, Mannheim

Status and phase: Completed; Phase 2

Conditions: Borderline Personality Disorder; Dissociation

Treatments: Drug: Placebo; Drug: Naltrexone

Study type: Interventional

Funder types: Other

Identifiers

NCT01133301

nal-diss-bpd (Other Identifier)

Naltrexone-BPD

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Naltrexone-Placebo

Active Comparator group

Description:

In the first three weeks of the study, 50 mg Naltrexone will be administrated, the following three three weeks placebo will be administrated.

Treatment:

Drug: Placebo

Drug: Naltrexone

Placebo-Naltrexone

Placebo Comparator group

Description:

The first three weeks, placebo will be administrated, the following three weeks 50 mg Naltrexone will be administrated.

Treatment:

Drug: Placebo

Drug: Naltrexone