A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Clinical Global Impressions - Improvement (CGI-I)
Overview
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 preventing PTSD relapse. The hypothesis is that levetiracetam will be safe and effective in preventing relapse of PTSD.
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 at least minimal improvement, 12 weeks of randomized, double-blind treatment with either levetiracetam or matching placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Tablets, no active ingredient, 1-6 tablets/day for 12 wks in the 2 nd phase of the trial.
Intervention: Placebo (Drug)
2
Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.
Intervention: levetiracetam (Drug)
2
Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.
Intervention: Levetriracetam (Drug)
Outcomes
Primary Outcomes
Clinical Global Impressions - Improvement (CGI-I)
Time Frame: 20 wks
Secondary Outcomes
- Sheehan Disability Inventory (SDI)(20 wks)
- 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)