Overview

Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack

Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
0
Participant gender:
All
Summary
This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Research Foundation for Mental Hygiene, Inc.
Collaborator:
National Institute of Mental Health (NIMH)
Treatments:
Paroxetine
Criteria
Inclusion Criteria:

- Posttraumatic Stress Disorder, chronic, related to World Trade Center Attacks

- Age 18-70

- CAPS score greater than 45

- Willingness to consent

- For women, negative pregnancy test and using adequate birth control

Exclusion Criteria:

- Prominent suicidal ideation

- Current psychotic disorder

- Unstable medical illness

- Women who are pregnant or nursing mothers

- Alcohol or substance use disorder in the past 3 months

- History of seizure disorder

- conditions that contraindicate use of paroxetine

- inability to tolerate a drug free period prior to beginning the study of 4 weeks for
MAOIs or fluoxetine and 2 weeks for other psychotropic drugs, except zolpidem for
insomnia.