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

Research Foundation for Mental Hygiene (RFMH)

Status and phase: Completed; Phase 4

Conditions: Posttraumatic Stress Disorder

Treatments: Drug: Paroxetine; Behavioral: Prolonged Exposure Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01130103

R01MH068173 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups, including a placebo group

Paroxetine

Experimental group

Description:

Paroxetine and Prolonged Exposure Therapy

Treatment:

Behavioral: Prolonged Exposure Therapy

Drug: Paroxetine

Placebo pill

Placebo Comparator group

Description:

Placebo pill plus Prolonged Exposure Therapy

Treatment:

Behavioral: Prolonged Exposure Therapy