Levetiracetam in Post-Traumatic Stress Disorder

NCT ID: NCT00413296

Last Updated: 2014-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2008-03-31

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.

Conditions

Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

2

Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.

Group Type: ACTIVE_COMPARATOR

levetiracetam

Intervention Type: DRUG

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

Levetriracetam

Intervention Type: DRUG

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.

Interventions

levetiracetam

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Levetriracetam

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.

Intervention Type: DRUG

Other Intervention Names

Keppra; Keppra

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Davidson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

7031-05-4R0

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00007843

Identifier Type: -

Identifier Source: org_study_id