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Difficulties in recruiting enough subjects
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The purpose of this study is to investigate whether naltrexone reduces the intensity and duration of flashbacks and dissociative states in patients with borderline personality disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Blinded sequential administration: naltrexon 50 mg (3 weeks)- placebo (3 weeks)- placebo (1 week) |
|
| 2 | Other | Blinded sequential administration: 200mg naltrexone (3 weeks) - placebo (3 weeks)- placebo (1 week) |
|
| 3 | Other | Blinded sequential administration: placebo (3 weeks) - 200mg naltrexone (3 weeks) - placebo (1 week) |
|
| 4 | Other | Blinded sequential administration: placebo (3 weeks) - 50mg naltrexone (3 weeks) - placebo (1 week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug | Daily oral administration (capsules): 50mg naltrexone and placebo or 200mg naltrexone and placebo or placebo and naltrexon 50mg or placebo and 200mg naltrexone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of dissociative symptoms | End of 3rd week treatment of naltrexon |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of flashbacks | End of 3rd week treatment of naltrexone | |
| Reduction of self-injurious behavior | End of 3rd week treatment of naltrexone | |
| Reduction of psychopathology (depression, anxiety, anger, borderline symptoms) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Bohus, M.D. | University of Heidelberg, Central Institute of Mental Health Mannheim | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Psychosomatic Medicine, Central Instiute of Mental Health | Mannheim | Baden-Würtemberg | 68159 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10846724 | Background | Schmahl C, Bohus M. [Treatment of dissociative symptoms in borderline personality disorder with naltrexone: supplementary comments]. Nervenarzt. 2000 May;71(5):427. doi: 10.1007/s001150050582. No abstract available. German. | |
| 10520978 | Background | Bohus MJ, Landwehrmeyer GB, Stiglmayr CE, Limberger MF, Bohme R, Schmahl CG. Naltrexone in the treatment of dissociative symptoms in patients with borderline personality disorder: an open-label trial. J Clin Psychiatry. 1999 Sep;60(9):598-603. doi: 10.4088/jcp.v60n0906. |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| D004213 | Dissociative Disorders |
| D016728 | Self-Injurious Behavior |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| End of 3rd week treatment of naltrexone |
| Safety regarding liver enzyme elevation | End of 3rd week treatment of naltrexone |
| Klinik Dr. Schlemmer GmbH, Center for Psychosomatic Medicine |
| Bad Wiessee |
| Bavaria |
| 83707 |
| Germany |
| Inntalklinik Simbach am Inn | Simbach | Bavaria | 84359 | Germany |
| Dept.of Psychiatry and Psychotherapy; Center of Neurology | Rostock | Mecklenburg-Vorpommern | 18147 | Germany |
| Dept.of Psychiatry and Psychotherapy , Rheinische Kliniken Köln | Cologne | North Rhine-Westphalia | 51109 | Germany |
| 10231814 | Background | Schmahl C, Stiglmayr C, Bohme R, Bohus M. [Treatment of dissociative symptoms in borderline patients with naltrexone]. Nervenarzt. 1999 Mar;70(3):262-4. doi: 10.1007/s001150050431. German. |
| 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. |
| 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 |