Overview

Early Intervention for Post Traumatic Stress Disorder (PTSD)

Status:
Withdrawn
Trial end date:
2011-04-01
Target enrollment:
0
Participant gender:
All
Summary
Over 150,000 soldiers are currently deployed in Iraq as part of Operation Iraqi Freedom (OIF), and 12% of returning OIF veterans have posttraumatic stress disorder (PTSD). Intervening soon after the trauma is critical for long-term outcomes, since with time traumatic memories become resistant to treatment. The current study will compare treatment with the selective serotonin reuptake inhibitor (SSRI) paroxetine to placebo in returning OIF veterans who have returned from Iraq in the past six months, who meet criteria for early PTSD. Assessment of PTSD symptoms, brain markers, neuropsychological testing of memory, and cortisol response to an Iraq-related traumatic script before and after the intervention are proposed to provide information about the effects of the interventions on PTSD symptoms and stress-responsive hormonal systems.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
US Department of Veterans Affairs
VA Office of Research and Development
Collaborator:
Emory University
Treatments:
Paroxetine
Criteria
Inclusion Criteria:

- Male and female veterans age 18-50

- Returned from Iraq Theater within the past six months

- Screen positive for PTSD related to Iraq deployment based on the PTSD Checklist

- Confirmed with PTSD based on the CAPS, including one month duration of symptoms

- Being discharged from active service from Iraq

- Provide written informed consent

Exclusion Criteria:

- History of loss of consciousness of more than one minute

- Psychotropic medication use within the previous four weeks

- History (based on the SCID) of lifetime or current alcohol or substance
abuse/dependence, schizophrenia, schizoaffective disorder, or bipolar disorder.

- Positive urine toxicology screen

- History of pre-deployment-related PTSD or partial PTSD based on the CAPS

- History of PTSD or partial PTSD related to a prior deployment

- Serious medical or neurological illness

- Pregnancy

- History of asthma

- Steroid usage, both inhaled and oral

- Seizure disorder

- Prenatal/perinatal substance exposure or trauma.