Clinical trial NCT01130103: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
anxiety disorders
trauma
Lead sponsor: Research Foundation for Mental Hygiene, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-05-25
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: Weeks 0,5,10
measure: Number of Participants Who Met Remission Criterion
timeFrame: Weeks 5,10
Secondary outcomes:
measure: Treatment Response at Weeks 5 and 10
timeFrame: weeks 5,10
measure: Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms
timeFrame: weeks 0,5,10
measure: Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10
timeFrame: weeks 0,5,10
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Franklin Schneier, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.