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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Franklin Schneier, Research Foundation for Mental Hygiene
ClinicalTrials.gov Identifier:
NCT01130103
First received: May 24, 2010
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination Treatment for PTSD After the WTC Attack

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: Weeks 0,5,10 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Franklin Schneier, MD New York State Psychiatric Institute
  More Information

No publications provided by Research Foundation for Mental Hygiene

Additional 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, R01MH068173
Study First Received: May 24, 2010
Results First Received: July 9, 2012
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013