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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01130103
First Posted: May 25, 2010
Last Update Posted: December 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Franklin Schneier, Research Foundation for Mental Hygiene
  Purpose
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.

Condition Intervention Phase
Posttraumatic Stress Disorder Drug: Paroxetine Behavioral: Prolonged Exposure Therapy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination Treatment for PTSD After the WTC Attack

Resource links provided by NLM:


Further study details as provided by Franklin Schneier, Research Foundation for Mental Hygiene:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


  • Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms [ Time Frame: 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 [ 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


Enrollment: 37
Study Start Date: March 2004
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paroxetine
Paroxetine and Prolonged Exposure Therapy
Drug: Paroxetine
Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks
Other Name: Paxil controlled release (CR)
Behavioral: Prolonged Exposure Therapy
Weekly for 10 weeks
Other Name: Cognitive Behavioral Therapy
Placebo Comparator: Placebo pill
Placebo pill plus Prolonged Exposure Therapy
Behavioral: Prolonged Exposure Therapy
Weekly for 10 weeks
Other Name: Cognitive Behavioral Therapy

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130103


Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Franklin Schneier, MD New York State Psychiatric Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Franklin Schneier, Research Psychiatrist, Research Foundation for Mental Hygiene
ClinicalTrials.gov Identifier: NCT01130103     History of Changes
Other Study ID Numbers: R01MH068173 ( U.S. NIH Grant/Contract )
First Submitted: May 24, 2010
First Posted: May 25, 2010
Results First Submitted: July 9, 2012
Results First Posted: August 14, 2012
Last Update Posted: December 4, 2012
Last Verified: November 2012

Keywords provided by Franklin Schneier, Research Foundation for Mental Hygiene:
PTSD
anxiety disorders
trauma

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors