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

Posttraumatic Stress Disorder Clinical Trial

Official title:

Combination Treatment for PTSD After the WTC Attack

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130103
• Other study ID #: R01MH068173
• Secondary ID: R01MH068173
• Status: Completed
• Phase: Phase 4
• First received: May 24, 2010
• Last updated: November 30, 2012
• Start date: March 2004
• Est. completion date: February 2010

Study information

• Verified date: November 2012
• Source: Research Foundation for Mental Hygiene, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Behavioral:
• Prolonged Exposure Therapy
Weekly for 10 weeks

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Research Foundation for Mental Hygiene, Inc.	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS)	PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD	Weeks 0,5,10	No
Primary	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	Weeks 5,10	No
Secondary	Treatment Response at Weeks 5 and 10	responder status: CGI-change score of 1 or 2; 1=very much improved, 2= much improved	weeks 5,10	No
Secondary	Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms	total score at weeks 0, 5, 10	weeks 0,5,10	No
Secondary	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	weeks 0,5,10	No