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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

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

NCT ID

NCT01130103

First Posted

May 24, 2010

Last Updated

November 30, 2012

Sponsor

Research Foundation for Mental Hygiene, Inc.

Collaborators

National Institute of Mental Health (NIMH)

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

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

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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