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| ID | Type | Description | Link |
|---|---|---|---|
| nal-diss-bpd | Other Identifier | Intern |
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| Name | Class |
|---|---|
| University of Freiburg | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone-Placebo | Active Comparator | In the first three weeks of the study, 50 mg Naltrexone will be administrated, the following three three weeks placebo will be administrated. |
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| Placebo-Naltrexone | Placebo Comparator | The first three weeks, placebo will be administrated, the following three weeks 50 mg Naltrexone will be administrated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug | 50 mg/d Naltrexone will be administrated during three weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Schmahl, MD | Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy, University of Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79104 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36375174 | Derived | 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. |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| D004213 | Dissociative Disorders |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Placebo | Drug | During 3 weeks of the study, Placebo will be administrated (daily) |
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The number and intensity of flashbacks are documented at the end of each week |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |