NCT01130103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2010

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 14, 2012

Completed
Last Updated

December 4, 2012

Status Verified

November 1, 2012

Enrollment Period

5.9 years

First QC Date

May 24, 2010

Results QC Date

July 9, 2012

Last Update Submit

November 30, 2012

Conditions

Posttraumatic Stress Disorder

Keywords

PTSDanxiety disorderstrauma

Outcome Measures

Primary Outcomes (2)

  • Clinician Administered PTSD Scale (CAPS)

    PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD

    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

    Weeks 5,10

Secondary Outcomes (3)

  • Treatment Response at Weeks 5 and 10

    weeks 5,10

  • Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms

    weeks 0,5,10

  • Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10

    weeks 0,5,10

Study Arms (2)

Paroxetine

EXPERIMENTAL

Paroxetine and Prolonged Exposure Therapy

Drug: ParoxetineBehavioral: Prolonged Exposure Therapy

Placebo pill

PLACEBO COMPARATOR

Placebo pill plus Prolonged Exposure Therapy

Behavioral: Prolonged Exposure Therapy

Interventions

ParoxetineDRUG

Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks

Also known as: Paxil controlled release (CR)
Paroxetine
Prolonged Exposure TherapyBEHAVIORAL

Weekly for 10 weeks

Also known as: Cognitive Behavioral Therapy
ParoxetinePlacebo pill

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 21908494DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersWounds and Injuries

Interventions

ParoxetineCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Franklin Schneier MD
Organization
Research Foundation for Mental Hygiene
frs1@columbia.edu
212-543-5368

Study Officials

  • Franklin Schneier, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Psychiatrist

Study Record Dates

First Submitted

May 24, 2010

First Posted

May 25, 2010

Study Start

March 1, 2004

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

December 4, 2012

Results First Posted

August 14, 2012

Record last verified: 2012-11

Locations

US(1)