Levetiracetam in Post-Traumatic Stress Disorder (PTSD)

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

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.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Drug: Placebo; Drug: levetiracetam; Drug: Levetriracetam

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Tablets, no active ingredient, 1-6 tablets/day for 12 wks in the 2 nd phase of the trial.	Drug: Placebo; Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.
Active Comparator: 2; Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.	Drug: levetiracetam; Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks; Other Names: Keppra; 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.; Other Names: Keppra

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: UCB Pharma
• Investigators: Principal Investigator: Jonathan Davidson, M.D., Duke University

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: December 18, 2006
• First Submitted That Met QC Criteria: December 18, 2006
• First Posted (Estimate): December 19, 2006

Study Record Updates

• Last Update Posted (Estimate): July 21, 2014
• Last Update Submitted That Met QC Criteria: July 18, 2014
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: PTSD; Anxiety; Relapse prevention; Pharmacotherapy; Levetiracetam
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: Pro00007843; 7031-05-4R0 (Other Identifier: DUMC)