Clinical trial NCT01133301: Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder
Official title: Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Borderline Personality Disorder
Dissociation
Keywords: Borderline Personality Disorder
Dissociation
Naltrexone
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
Collaborators: name: University of Freiburg
First posted: 2010-05-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: 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)
timeFrame: Oct. 1998-Oct 2001
Secondary outcomes:
measure: The number, the method, and the severity of non-suicidal self-injurious acts during the last week.
measure: Number and intensity of flashbacks during the last week.
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Freiburg
state: Baden Württemberg
Study officials:
affiliation: Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine
name: Christian Schmahl, MD
role: STUDY_CHAIR
References:
citation: 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.