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

NCT ID: NCT01133301

Last Updated: 2010-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-08-31
• Study Completion Date: 2001-10-31

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).

Conditions

Borderline Personality Disorder; Dissociation

Keywords

Borderline Personality Disorder; Dissociation; Naltrexone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Naltrexone

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Placebo-Naltrexone

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

Group Type: PLACEBO_COMPARATOR

Naltrexone

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Interventions

Naltrexone

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Freiburg

OTHER

Sponsor Role: collaborator

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Principal Investigators

Christian Schmahl, MD

Role: STUDY_CHAIR

Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine

Locations

Department of Psychiatry and Psychotherapy, University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Countries

Germany

References

Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.

Reference Type: DERIVED

PMID: 36375174 (View on PubMed)

Other Identifiers

nal-diss-bpd

Identifier Type: OTHER

Identifier Source: secondary_id

Naltrexone-BPD

Identifier Type: -

Identifier Source: org_study_id