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Completed

NCT Number: NCT01130103

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

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Key information

Conditions

Posttraumatic Stress Disorder Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

paroxetine

Drug

Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks

Other names: Paxil controlled release (CR)

Prolonged Exposure Therapy

Behavioral

Weekly for 10 weeks

Other names: Cognitive Behavioral Therapy

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms

    Time frame: weeks 0,5,10

    total score at weeks 0, 5, 10

  3. 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

Sponsors and collaborators

Lead sponsor

Research Foundation for Mental Hygiene, Inc.

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Combination Treatment for PTSD After the WTC Attack

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
May 25, 2010
Registry last updated
Dec 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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