Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder
Primary Purpose
Borderline Personality Disorder, Dissociation
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Naltrexone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline Personality Disorder, Dissociation, Naltrexone
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
Sites / Locations
- Department of Psychiatry and Psychotherapy, University of Freiburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Naltrexone-Placebo
Placebo-Naltrexone
Arm Description
In the first three weeks of the study, 50 mg Naltrexone will be administrated, the following three three weeks placebo will be administrated.
The first three weeks, placebo will be administrated, the following three weeks 50 mg Naltrexone will be administrated.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01133301
First Posted
May 17, 2010
Last Updated
May 26, 2010
Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
University of Freiburg
1. Study Identification
Unique Protocol Identification Number
NCT01133301
Brief Title
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
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
August 1998 (undefined)
Primary Completion Date
August 2001 (Actual)
Study Completion Date
October 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
University of Freiburg
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Dissociation
Keywords
Borderline Personality Disorder, Dissociation, Naltrexone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naltrexone-Placebo
Arm Type
Active Comparator
Arm Description
In the first three weeks of the study, 50 mg Naltrexone will be administrated, the following three three weeks placebo will be administrated.
Arm Title
Placebo-Naltrexone
Arm Type
Placebo Comparator
Arm Description
The first three weeks, placebo will be administrated, the following three weeks 50 mg Naltrexone will be administrated.
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
50 mg/d Naltrexone will be administrated during three weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
During 3 weeks of the study, Placebo will be administrated (daily)
Primary Outcome Measure Information:
Title
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)
Time Frame
Oct. 1998-Oct 2001
Secondary Outcome Measure Information:
Title
The number, the method, and the severity of non-suicidal self-injurious acts during the last week.
Description
The number, method and the severity of non-suicidal self-injurious acts are documented at the end of each week.
Title
Number and intensity of flashbacks during the last week.
Description
The number and intensity of flashbacks are documented at the end of each week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Schmahl, MD
Organizational Affiliation
Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University of Freiburg
City
Freiburg
State/Province
Baden Württemberg
ZIP/Postal Code
79104
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
36375174
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.
Results Reference
derived
Learn more about this trial
Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder
We'll reach out to this number within 24 hrs