Combination Treatment for PTSD After the WTC Attack
Overview
- Phase
- Phase 4
- Intervention
- Paroxetine
- Conditions
- Posttraumatic Stress Disorder
- Sponsor
- Research Foundation for Mental Hygiene, Inc.
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Clinician Administered PTSD Scale (CAPS)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
Detailed Description
Selective serotonin reuptake inhibitor (SSRI) medication is often recommended in combination with cognitive behavioral therapies for PTSD, but combined initial treatment of PTSD has not been studied under controlled conditions. Also, there are few studies of either treatment in survivors of terrorism. This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the SSRI paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.
Investigators
Franklin Schneier
Research Psychiatrist
Research Foundation for Mental Hygiene, Inc.
Eligibility 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.
Arms & Interventions
Paroxetine
Paroxetine and Prolonged Exposure Therapy
Intervention: Paroxetine
Paroxetine
Paroxetine and Prolonged Exposure Therapy
Intervention: Prolonged Exposure Therapy
Placebo pill
Placebo pill plus Prolonged Exposure Therapy
Intervention: Prolonged Exposure Therapy
Outcomes
Primary Outcomes
Clinician Administered PTSD Scale (CAPS)
Time Frame: Weeks 0,5,10
PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD
Number of Participants Who Met Remission Criterion
Time Frame: Weeks 5,10
remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1
Secondary Outcomes
- Treatment Response at Weeks 5 and 10(weeks 5,10)
- Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms(weeks 0,5,10)
- Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10(weeks 0,5,10)