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

Phase 4

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Drug: Paroxetine; Behavioral: Prolonged Exposure Therapy

• Registration Number: NCT01130103
• Lead Sponsor: Research Foundation for Mental Hygiene, Inc.

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.

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-05-24
• Study First Posted: 2010-05-25
• Results First Submitted: 2012-07-09
• Results First Submitted QC: 2012-07-09
• Results First Posted: 2012-08-14
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paroxetine	Prolonged Exposure Therapy	Paroxetine and Prolonged Exposure Therapy
Placebo pill	Prolonged Exposure Therapy	Placebo pill plus Prolonged Exposure Therapy
Paroxetine	Paroxetine	Paroxetine and Prolonged Exposure Therapy

Primary Outcome Measures

Name	Time	Method
Clinician Administered PTSD Scale (CAPS)	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	Weeks 5,10	remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States