Phase 4 N=37 Randomized Quadruple-blind Treatment

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

Posttraumatic Stress Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01130103 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2012

Primary outcome: Primary: Clinician Administered PTSD Scale (CAPS) — 72.6; 65.4; 40.7; 49.0 units on a scale — p=.01

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Paroxetine (Drug); Prolonged Exposure Therapy (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Research Foundation for Mental Hygiene, Inc.
Primary completion: Feb 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinician Administered PTSD Scale (CAPS)	72.6; 65.4; 40.7; 49.0; 21.5; 35.6	.01 sig
PRIMARY Number of Participants Who Met Remission Criterion	2; 0; 8; 3	.03 sig
SECONDARY Treatment Response at Weeks 5 and 10	6; 6; 12; 7	—
SECONDARY Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms	16.9; 16.6; 11.7; 11.8; 7.7; 11.4	—
SECONDARY Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10	47.1; 45.4; 55.5; 59.4; 67.9; 54.8	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01130103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.