NCT00633685

Brief Summary

Three hundred (300) male or female outpatients, over 18 years of age, will be enrolled in this study to determine whether fluoxetine can be used as a treatment for Posttraumatic Stress Disorder in soldiers recently returning from combat exposure. There will be two phases to the study. In Phase I Fluoxetine + usual psychological care will be compared with Placebo + usual psychological care over a 12-week period. Subsequently, in Phase II all subjects will be offered the opportunity to enroll in a 20-week open-label trial on Fluoxetine. If response is inadequate, adjunctive treatment with either buspirone or bupropion will be offered. The investigational drugs are Fluoxetine, Buspirone and Bupropion. All are commercially available.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 4, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
2 years until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 25, 2010

Status Verified

February 1, 2010

Enrollment Period

2.3 years

First QC Date

March 4, 2008

Last Update Submit

May 24, 2010

Conditions

Posttraumatic Stress Disorder, Combat-related

Keywords

Posttraumatic Stress DisorderFluoxetineFactors predicting responseResiliencePharmacologic augmentation strategies

Outcome Measures

Primary Outcomes (1)

  • Clinician Administered PTSD Scale

    12-Weeks

Secondary Outcomes (1)

  • PTSD Symptom Checklist

    Every follow-up encounter (weeks 2-32)

Study Arms (2)

Fluoxetine

EXPERIMENTAL

Receives Fluoxetine at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response

Drug: FluoxetineDrug: Placebo

Placebo

PLACEBO COMPARATOR
Drug: FluoxetineDrug: Placebo

Interventions

FluoxetineDRUG

Fluoxetine will be administered at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response

Also known as: Prozac
FluoxetinePlacebo
PlaceboDRUG

Placebo will be empty gelatin capsules that are identical in size and shape to active treatment

Also known as: Gelatin capsule
FluoxetinePlacebo

Eligibility Criteria

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

You may qualify if:

  • Veteran of the OEF/OIF war campaigns with violence exposure sufficient to qualify for a diagnosis of PTSD
  • DSM-IV diagnosis of Post-Traumatic Stress Disorder as determined by the CAPS.
  • Entry Total CAPS score of at least 65
  • No exposure to psychotropic medications except for zolpidem for at least two weeks (five weeks for fluoxetine) prior to the baseline assessments.
  • If female, a negative beta-human chorionic gonadotropin pregnancy test and willing to use oral contraceptives

You may not qualify if:

  • History of intolerance to fluoxetine
  • History of lack of responsivity to a 60 mg daily dose of fluoxetine
  • Current or past history of Bipolar Disorder or Schizophrenia
  • Diagnosis of Major Depressive Disorder, Obsessive-Compulsive Disorder, or Other Anxiety Disorder, unless PTSD is the principal focus of treatment and the onset of PTSD preceded that of the concurrent disorders
  • Significant history of suicidal or homicidal behavior/ideation
  • Substance dependence in the past 6 months
  • Serious general medical condition that would risk the patient being able to complete the pharmacological trial with fluoxetine
  • Concomitant use of other antidepressants, antipsychotics or mood stabilizers
  • If female, pregnancy or unwilling to use oral contraceptives
  • Participation in another research drug trial within 30-days of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carl R. Darnall Army Medical Center

Fort Hood, Texas, 76544-4752, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

FluoxetineGelatin

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Paul B Hicks, M.D., Ph.D.

    Central Texas Veterans Health Care System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul B Hicks, M.D., Ph.D.

CONTACT

254-743-2643paul.hicks@va.gov

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

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 12, 2008

Study Start

March 1, 2010

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

May 25, 2010

Record last verified: 2010-02

Locations

US(1)