Phase 4
Completed N=37
Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack
Source: ClinicalTrials.gov NCT01130103 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Clinician Administered PTSD Scale (CAPS) — 72.6; 65.4; 40.7; 49.0 units on a scale — p=.01
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.
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 | — |
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.
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. Informational only — not medical advice.