Early Intervention for Post Traumatic Stress Disorder (PTSD)

NCT00641173 | Withdrawn DMC

• 1 other identifier: MHBA-009-06F
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Post-Traumatic Stress Disorders

Keywords

PTSD; cortisol; hippocampus; memory

Outcome Measures

Primary Outcomes (1)

• CAPS

  three months

Secondary Outcomes (3)

• hippocampal volume and NAA

  three months

• memory

  three months

• cortisol response to stress

  three months

Study Arms (2)

1

EXPERIMENTAL

paroxetine v placebo

Drug: paroxetine

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

paroxetine DRUG

treatment with SSRI paroxetine

1

placebo DRUG

treatment with placebo

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Emory University: collaborator

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Doug Bremner, MD

  Atlanta VA Medical and Rehab Center, Decatur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 24, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 26, 2015

Record last verified: 2015-06