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

NCT ID: NCT01130103

Last Updated: 2012-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Posttraumatic Stress Disorder

Keywords

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PTSD anxiety disorders trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paroxetine

Paroxetine and Prolonged Exposure Therapy

Group Type EXPERIMENTAL

Paroxetine

Intervention Type DRUG

Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks

Prolonged Exposure Therapy

Intervention Type BEHAVIORAL

Weekly for 10 weeks

Placebo pill

Placebo pill plus Prolonged Exposure Therapy

Group Type PLACEBO_COMPARATOR

Prolonged Exposure Therapy

Intervention Type BEHAVIORAL

Weekly for 10 weeks

Interventions

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Paroxetine

Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks

Intervention Type DRUG

Prolonged Exposure Therapy

Weekly for 10 weeks

Intervention Type BEHAVIORAL

Other Intervention Names

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Paxil controlled release (CR) Cognitive Behavioral Therapy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Franklin Schneier

Research Psychiatrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Franklin Schneier, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21908494 (View on PubMed)

Other Identifiers

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R01MH068173

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH068173

Identifier Type: NIH

Identifier Source: org_study_id

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