NCT00413296 (PTSD) is a Phase 2/Phase 3 clinical trial of levetiracetam in Post-Traumatic Stress Disorder, sponsored by Duke University.

Who is sponsoring NCT00413296?

NCT00413296 is sponsored by Duke University.

What drugs are being tested in NCT00413296?

Interventions in NCT00413296: levetiracetam, Placebo, Levetriracetam.

What condition does NCT00413296 study?

NCT00413296 studies Post-Traumatic Stress Disorder.

Is NCT00413296 still recruiting?

NCT00413296 is currently completed. Last updated 18 July 2014.

Last reviewed 2014-07-18 · How we verify

NCT00413296: PTSD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2/Phase 3 Last updated 18 July 2014

What this trial tests

Phase 2/Phase 3 trial testing levetiracetam in Post-Traumatic Stress Disorder in 16 participants. Completed in 1 March 2008.

Timeline

1 November 2005

Primary endpoint
1 September 2007

1 March 2008

Quick facts

Lead sponsor	Duke University
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	16
Start date	1 November 2005
Primary completion	1 September 2007
Estimated completion	1 March 2008
Sites	1 location across United States

Drugs / interventions tested

levetiracetam (levetiracetam) — full drug profile →
Placebo
Levetriracetam — full drug profile →

Conditions studied

Post-Traumatic Stress Disorder — all drugs for Post-Traumatic Stress Disorder →

Sponsor

Duke University

Who can join

Adults 18 to 65, any sex, with Post-Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Clinical Global Impressions - Improvement (CGI-I)
Time frame: 20 wks

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmacotherapy for post traumatic stress disorder (PTSD).
Williams T, Phillips NJ, Stein DJ, Ipser JC. · · 2022 · cited 62× · PMID 35234292 · DOI 10.1002/14651858.cd002795.pub3

Verify or expand the search:

Other trials of levetiracetam

Trials testing the same drug.

NCT03196466 — Population Pharmacokinetics of Antiepileptic in Pediatrics · completed
NCT02002819 — Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability · Phase 2 · completed
NCT01857934 — Therapy for Children With Advanced Stage Neuroblastoma · Phase 2 · completed
NCT01345058 — Add on Lacosamide Versus High Dose Monotherapy · Phase 3 · completed

Other Duke University trials

Trials by the same sponsor.

NCT07216456 — Vaginal Dilator Therapy After Pelvic Radiation · NA · not yet recruiting
NCT07519317 — Dosing and Deployment Trial: A Home-based Optokinetic Treatment · NA · not yet recruiting
NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07216963 — The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study · NA · not yet recruiting
NCT07459218 — IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00413296 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 18 July 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00413296.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing