Levetiracetam in Post-Traumatic Stress Disorder

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00413296

Acronym

PTSD

Enrollment

Registered

2006-12-19

Start date

2005-11-30

Completion date

2008-03-31

Last updated

2014-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSD, Anxiety, Pharmacotherapy, Levetiracetam, Relapse prevention

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.

Interventions

DRUGlevetiracetam

Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks

DRUGPlacebo

Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.

DRUGLevetriracetam

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Clinical Global Impressions - Improvement (CGI-I)	20 wks

Secondary

Measure	Time frame
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
Davidson Trauma Scale (DTS)	20 wks
Work Productivity and Activity Improvement Questionnaire (WPAI)	20 wks
Sheehan Disability Inventory (SDI)	20 wks
Pittsburgh Sleep Quality Index	20 wks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026