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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


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
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