Clinical trial NCT00413296: Levetiracetam in Post-Traumatic Stress Disorder
Official title: A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Post-Traumatic Stress Disorder
Keywords: PTSD
Anxiety
Pharmacotherapy
Levetiracetam
Relapse prevention
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2006-12-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Global Impressions - Improvement (CGI-I)
timeFrame: 20 wks
Secondary outcomes:
measure: Davidson Trauma Scale (DTS)
timeFrame: 20 wks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 20 wks
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: 20 wks
measure: 36-item Short Form Health Survey (SF-36)
timeFrame: 20 wks
measure: Pittsburgh Sleep Quality Index
timeFrame: 20 wks
measure: Work Productivity and Activity Improvement Questionnaire (WPAI)
timeFrame: 20 wks
measure: Sheehan Disability Inventory (SDI)
timeFrame: 20 wks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jonathan Davidson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: