Levetiracetam in Post-Traumatic Stress Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Drug: levetiracetam
* Drug: Placebo
* Drug: Levetriracetam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 18-65 primary diagnosis of PTSD based on DSM-IV criteria and assessed by the MINI International Neuropsychiatric Interview (MINI) Davidson Trauma Scale (DTS) score of at least 40 on screening ability to provide written informed consent Exclusion Criteria: any primary DSM-IV Axis I disorder other than PTSD substance abuse during the last 6 months a clinically unstable medical condition or clinically significant laboratory abnormalities suicide risk or serious suicide attempt during the last year concurrent use of psychotropic medications including benzodiazepines, barbiturates, antiepileptic drugs, antidepressants, buspirone, dietary supplements or herbal or homeopathic remedies with psychotropic effects recent (within the last 3 months) initiation of cognitive behavioral therapy failure of a previous trial of levetiracetam at 2000 mg/day pregnancy or lactation women of childbearing potential who are unwilling to practice an acceptable method of contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Tablets, no active ingredient, 1-6 tablets/day for 12 wks in the 2 nd phase of the trial. | Drug: Placebo<br>* Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.<br>|
| Active Comparator: 2<br>Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study. | Drug: levetiracetam<br>* Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks<br>* Other names: Keppra;Drug: Levetriracetam<br>* 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.<br>* Other names: Keppra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions - Improvement (CGI-I) |  | 20 wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Davidson Trauma Scale (DTS) |  | 20 wks | 
| Hospital Anxiety and Depression Scale (HADS) |  | 20 wks | 
| Connor-Davidson Resilience Scale (CD-RISC) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Anxiety, Pharmacotherapy, Levetiracetam, Relapse prevention