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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Combination Treatment for PTSD After the WTC Attack

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: Paroxetine
* Behavioral: Prolonged Exposure Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paroxetine<br>Paroxetine and Prolonged Exposure Therapy | Drug: Paroxetine<br>* Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks<br>* Other names: Paxil controlled release (CR);Behavioral: Prolonged Exposure Therapy<br>* Weekly for 10 weeks<br>* Other names: Cognitive Behavioral Therapy;|
| Placebo Comparator: Placebo pill<br>Placebo pill plus Prolonged Exposure Therapy | Behavioral: Prolonged Exposure Therapy<br>* Weekly for 10 weeks<br>* Other names: Cognitive Behavioral Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale (CAPS) | PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD | Weeks 0,5,10 | 
| Number of Participants Who Met Remission Criterion | remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1 | Weeks 5,10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Response at Weeks 5 and 10 | responder status: CGI-change score of 1 or 2 1=very much improved, 2= much improved | weeks 5,10 | 
| Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms | total score at weeks 0, 5, 10 | weeks 0,5,10 | 
| Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10 | Measures life enjoyment and satisfaction across 16 domains 16 = very poor quality of life to 80 =very good quality of life | weeks 0,5,10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, anxiety disorders, trauma