Status:
COMPLETED
Levetiracetam in Post-Traumatic Stress Disorder
Lead Sponsor:
Duke University
Collaborating Sponsors:
UCB Pharma
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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 preventin...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00413296
Start Date
November 1 2005
End Date
March 1 2008
Last Update
July 21 2014
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705