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

Borderline Personality Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133301
• Other study ID #: Naltrexone-BPD
• Secondary ID: nal-diss-bpd
• Status: Completed
• Phase: Phase 2
• First received: May 17, 2010
• Last updated: May 26, 2010
• Start date: August 1998
• Est. completion date: October 2001

Study information

• Verified date: May 2010
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2001
• Est. primary completion date: August 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Dissociation
• Personality Disorders

Intervention

Drug:
• Naltrexone
50 mg/d Naltrexone will be administrated during three weeks.
• Placebo
During 3 weeks of the study, Placebo will be administrated (daily)

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, University of Freiburg	Freiburg	Baden Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim	University of Freiburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.		No
Secondary	Number and intensity of flashbacks during the last week.	The number and intensity of flashbacks are documented at the end of each week		No