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| ID | Type | Description | Link |
|---|---|---|---|
| 7031-05-4R0 | Other Identifier | DUMC |
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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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The purpose of this study is to evaluate the short-term efficacy and safety of levetiracetam in post-traumatic stress disorder (PTSD) and to evaluate continuation effects of levetiracetam in preventing PTSD relapse. The hypothesis is that levetiracetam will be safe and effective in preventing relapse of PTSD.
This is an investigator-initiated, single site study, consisting of two phases: 8 weeks of open label treatment with levetiracetam (500-2000 mg/day) in patients with PTSD, and in those who demonstrate at least minimal improvement, 12 weeks of randomized, double-blind treatment with either levetiracetam or matching placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Tablets, no active ingredient, 1-6 tablets/day for 12 wks in the 2 nd phase of the trial. |
|
| 2 | Active Comparator | Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levetiracetam | Drug | Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions - Improvement (CGI-I) | 20 wks |
| Measure | Description | Time Frame |
|---|---|---|
| Davidson Trauma Scale (DTS) | 20 wks | |
| Hospital Anxiety and Depression Scale (HADS) | 20 wks | |
| Connor-Davidson Resilience Scale (CD-RISC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Davidson, M.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Placebo | Drug | Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study. |
|
| Levetriracetam | Drug | Tablets, 500 mg each (1-6 tablets/day) for 8 wks during the open label phase and for 12 wks during the 2nd phase of the study. |
|
|
| 20 wks |
| 36-item Short Form Health Survey (SF-36) | 20 wks |
| Pittsburgh Sleep Quality Index | 20 wks |
| Work Productivity and Activity Improvement Questionnaire (WPAI) | 20 wks |
| Sheehan Disability Inventory (SDI) | 20 wks |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |