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

November 30, 2012 updated by: Franklin Schneier, Research Foundation for Mental Hygiene, Inc.

Combination Treatment for PTSD After the WTC Attack

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Paroxetine
Paroxetine and Prolonged Exposure Therapy
Drug: Paroxetine
Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks
Other Names:
  • Paxil controlled release (CR)
Behavioral: Prolonged Exposure Therapy
Weekly for 10 weeks
Other Names:
  • Cognitive Behavioral Therapy
PLACEBO_COMPARATOR: Placebo pill
Placebo pill plus Prolonged Exposure Therapy
Behavioral: Prolonged Exposure Therapy
Weekly for 10 weeks
Other Names:
  • Cognitive Behavioral Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Weeks 0,5,10
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
Weeks 5,10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Response at Weeks 5 and 10
Time Frame: weeks 5,10

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
Time Frame: weeks 0,5,10
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
Time Frame: 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
weeks 0,5,10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Foundation for Mental Hygiene, Inc.

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (ESTIMATE)

May 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH068173 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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