Post-Traumatic Stress Disorder Clinical Trial
— PTSDOfficial title:
A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder
Verified date | June 2010 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | March 2008 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | UCB Pharma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Global Impressions - Improvement (CGI-I) | 20 wks | Yes | |
Secondary | Davidson Trauma Scale (DTS) | 20 wks | Yes | |
Secondary | Hospital Anxiety and Depression Scale (HADS) | 20 wks | Yes | |
Secondary | Connor-Davidson Resilience Scale (CD-RISC) | 20 wks | Yes | |
Secondary | 36-item Short Form Health Survey (SF-36) | 20 wks | Yes | |
Secondary | Pittsburgh Sleep Quality Index | 20 wks | Yes | |
Secondary | Work Productivity and Activity Improvement Questionnaire (WPAI) | 20 wks | Yes | |
Secondary | Sheehan Disability Inventory (SDI) | 20 wks | Yes |
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