Levetiracetam in Post-Traumatic Stress Disorder

Post-Traumatic Stress Disorder Clinical Trial

— PTSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413296
• Other study ID #: Pro00007843
• Secondary ID: 7031-05-4R0
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 18, 2006
• Last updated: July 18, 2014
• Start date: November 2005
• Est. completion date: March 2008

Study information

• Verified date: June 2010
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• levetiracetam
Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks
• Placebo
Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impressions - Improvement (CGI-I)		20 wks	Yes
Secondary	Davidson Trauma Scale (DTS)		20 wks	Yes
Secondary	Hospital Anxiety and Depression Scale (HADS)		20 wks	Yes
Secondary	Connor-Davidson Resilience Scale (CD-RISC)		20 wks	Yes
Secondary	36-item Short Form Health Survey (SF-36)		20 wks	Yes
Secondary	Pittsburgh Sleep Quality Index		20 wks	Yes
Secondary	Work Productivity and Activity Improvement Questionnaire (WPAI)		20 wks	Yes
Secondary	Sheehan Disability Inventory (SDI)		20 wks	Yes