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| Name | Class |
|---|---|
| Whanin Pharmaceutical Company | INDUSTRY |
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The goal of this clinical trial is to learn if naltrexone works to treat nonsuicidal self-injurious behavior in adolescents and adults.
Recruiting participants with nonsuicidal self-injurious behavior and randomizing them to the experiment group and the control group at a 1:1 ratio, the test group administers the experiment drug naltrexone along with the general treatment, and the control group provides a placebo. Clinical evaluation including the frequency of self-injurious behavior is conducted every two weeks. The investigator and participants will double-blinded. Analyze the relationship between changes in clinical symptoms and socio-demographic characteristics, diagnosis, clinical characteristics, and anticipated to discover predictors of treatment effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | naltrexone 50mg |
|
| comparison group | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug | naltrexone 50mg for 6 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of nonsuicidal self-injurous behavior | Total number of nonsuicidal self-injurous behavior during study period | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Deliberate Self-harm Inventory | change of NSSI frequency acquired by Deliberate Self-harm Inventory (the outcome of this scale does not have score) | 6 weeks |
| Clinical Global Impressions | change of Clinical Global Impressions scale the minimum and maximum values are 1 to 7, higher scores mean worse outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dae Hun Kang, M.D | Contact | 82 + 02-2072-2457 | redlinnet@daum.net |
| Name | Affiliation | Role |
|---|---|---|
| Yong Min Ahn, M.D, Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| ID | Term |
|---|---|
| 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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| Placebo | Drug | placebo for 6 weeks |
|
| 6 weeks |
| Obsessive Compulsive Drinking Scale | change of Obsessive Compulsive Drinking Scale the minimum and mixiumum values are 0 to 40, higher scores mean a worse outcome | 6 weeks |
| Eating Disorder Examination-Questionnaire | change of Eating Disorder Examination-Questionnaire the minimum and mixiumum values are 0 to 6, higher scores mean a worse outcome | 6 weeks |
| 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 |