Department of Psychiatry and Psychotherapy, University of Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany
NCT Number: NCT01133301
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.
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Notify Me18 year–50 year
Female
Interventional
Phase 2
Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50 mg/d Naltrexone will be administrated during three weeks.
During 3 weeks of the study, Placebo will be administrated (daily)
Time frame: Oct. 1998-Oct 2001
The number, method and the severity of non-suicidal self-injurious acts are documented at the end of each week.
The number and intensity of flashbacks are documented at the end of each week
Central Institute of Mental Health, Mannheim
Other
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