Levetiracetam in Post-Traumatic Stress Disorder

Phase 2

Completed

• Conditions: Post-Traumatic Stress Disorder
• Interventions: Drug: Placebo; Drug: levetiracetam; Drug: Levetriracetam

• Registration Number: NCT00413296
• Lead Sponsor: Duke University

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 Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-12-18
• Study First Submitted QC: 2006-12-18
• Study First Posted: 2006-12-19
• Primary Completion: 2007-09
• Study Completion: 2008-03
• Status Verified: 2010-06
• Last Update Submitted: 2014-07-18
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Tablets, no active ingredient, 1-6 tablets/day for 12 wks in the 2 nd phase of the trial.
2	levetiracetam	Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.
2	Levetriracetam	Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.

Primary Outcome Measures

Name	Time	Method
Clinical Global Impressions - Improvement (CGI-I)	20 wks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States