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

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Paroxetine
Prolonged Exposure Therapy
Sponsored by
Research Foundation for Mental Hygiene, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, anxiety disorders, trauma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Paroxetine

Placebo pill

Arm Description

Paroxetine and Prolonged Exposure Therapy

Placebo pill plus Prolonged Exposure Therapy

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS)
PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD
Number of Participants Who Met Remission Criterion
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
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
total score at weeks 0, 5, 10
Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10
Measures life enjoyment and satisfaction across 16 domains 16 = very poor quality of life to 80 =very good quality of life

Full Information

First Posted
May 24, 2010
Last Updated
November 30, 2012
Sponsor
Research Foundation for Mental Hygiene, Inc.
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01130103
Brief Title
Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack
Official Title
Combination Treatment for PTSD After the WTC Attack
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Foundation for Mental Hygiene, Inc.
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, anxiety disorders, trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paroxetine
Arm Type
Experimental
Arm Description
Paroxetine and Prolonged Exposure Therapy
Arm Title
Placebo pill
Arm Type
Placebo Comparator
Arm Description
Placebo pill plus Prolonged Exposure Therapy
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Other Intervention Name(s)
Paxil controlled release (CR)
Intervention Description
Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy
Other Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Weekly for 10 weeks
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Description
PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD
Time Frame
Weeks 0,5,10
Title
Number of Participants Who Met Remission Criterion
Description
remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1
Time Frame
Weeks 5,10
Secondary Outcome Measure Information:
Title
Treatment Response at Weeks 5 and 10
Description
responder status: CGI-change score of 1 or 2 1=very much improved, 2= much improved
Time Frame
weeks 5,10
Title
Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms
Description
total score at weeks 0, 5, 10
Time Frame
weeks 0,5,10
Title
Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10
Description
Measures life enjoyment and satisfaction across 16 domains 16 = very poor quality of life to 80 =very good quality of life
Time Frame
weeks 0,5,10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franklin Schneier, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21908494
Citation
Schneier FR, Neria Y, Pavlicova M, Hembree E, Suh EJ, Amsel L, Marshall RD. Combined prolonged exposure therapy and paroxetine for PTSD related to the World Trade Center attack: a randomized controlled trial. Am J Psychiatry. 2012 Jan;169(1):80-8. doi: 10.1176/appi.ajp.2011.11020321. Epub 2011 Sep 9.
Results Reference
derived

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

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