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

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ClinicalTrials.gov Identifier: NCT01130103
Recruitment Status : Completed
First Posted : May 25, 2010
Results First Posted : August 14, 2012
Last Update Posted : December 4, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Franklin Schneier, Research Foundation for Mental Hygiene, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Drug: Paroxetine Behavioral: Prolonged Exposure Therapy Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
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
Study Start Date : March 2004
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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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
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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
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Principal Investigator: Franklin Schneier, MD New York State Psychiatric Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Franklin Schneier, Research Psychiatrist, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier: NCT01130103    
Other Study ID Numbers: R01MH068173 ( U.S. NIH Grant/Contract )
R01MH068173 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2010    Key Record Dates
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, Inc.:
PTSD
anxiety disorders
trauma
Additional relevant MeSH terms:
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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