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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
37
Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks
Weekly for 10 weeks
New York State Psychiatric Institute
New York, New York, United States
Clinician Administered PTSD Scale (CAPS)
PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD
Time frame: Weeks 0,5,10
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
Time frame: Weeks 5,10
Treatment Response at Weeks 5 and 10
responder status: CGI-change score of 1 or 2 1=very much improved, 2= much improved
Time frame: weeks 5,10
Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms
total score at weeks 0, 5, 10
Time frame: 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
Time frame: weeks 0,5,10
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