Posttraumatic Stress Disorder, Combat-relatedPhase 4NCT00633685
Predictors of Treatment Response to Fluoxetine in PTSD Following a Recent History of War Zone Stress Exposure
A Phase 4 study testing Fluoxetine in people with Posttraumatic Stress Disorder, Combat-related, run by TEMPVA Research Group, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Combat-related
- What is being tested?
- Fluoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Aug 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544-4752
Michael Adams, Ph.D., 254-286-7804, michael.adams@amedd.army.mil
Michael Adams, Ph.D.
About this study
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.
Read the detailed description
While most soldiers exposed to the stresses of the war-zone exhibit psychological resilience, about one-fifth become psychological casualties of war. The fact that such a significant number of soldiers have difficulty adapting to life after war exposure suggests that we need to have well-defined treatments that are effective and cost-efficient. Currently, recommendations for first-line pharmacological management of Post-Traumatic Stress Disorder focus on the use of selective serotonin re-uptake inhibitors (SSRIs) such as fluoxetine. Despite this recommendation by the DoD/VA Clinical Practice Guidelines, there have not been any studies evaluating the effectiveness of these medications in patients that have recently been exposure to war-zone stressors. In fact, studies in Vietnam Era veterans have shown limited effectiveness of SSRIs for PTSD. In addition, there is very limited information available to understand the factors that influence whether a particular soldier will respond to treatment with an SSRI. This study is designed to determine whether fluoxetine is an effective treatment for PTSD and associated conditions in soldiers with recent war-zone exposure, as well as determine whether response to SSRIs is related to the severity of the trauma exposure and PTSD symptoms, psychological resilience, adequacy of social supports (family, extra-military and military), post-deployment stressors and life adversity, or the degree of any cognitive impairment.
After informed consent is given, fluoxetine (150 subjects) or placebo (150 subjects) will be administered for 12 weeks in doses from 20 mg daily up to 60 mg daily to active duty soldiers who are already receiving usual psychological care in the Resilience and Restoration Center of the Carl R. Darnall Army Medical Center at Ft. Hood. At the conclusion of this initial phase of the study, all participants will receive fluoxetine in doses up to 80 mg daily for an additional 20 weeks. All participants will be regularly monitored to determine changes in their PTSD symptoms. If a subject does not have at least a 50% improvement after being given 80 mg daily of fluoxetine for 4 weeks, then they will be randomly assigned to also receive either bupropion SR (150 mg daily) or buspirone (up to 40 mg daily) in an attempt to amplify the response to fluoxetine. Statistical analyses will be used to determine which factors provided the greatest influence on the response to these medication trials.
Each subject will be asked to receive a physical exam, give medical history information, and receive a diagnostic interview prior to participation in the study. After being randomly assigned to treatment, subjects will have interview or questionnaire assessments at weeks 2, 4, 6, 8, 12, 16, 20, 24, 28 and 32. Based solely on the degree of response as measured by the PTSD Checklist (a questionnaire that will be administered at each study visit), the dosage of study medication fluoxetine or placebo capsules will be adjusted by a pre-determined schedule.
- Being tested
- Fluoxetine, Placebo
- Keywords
- Posttraumatic Stress Disorder, Fluoxetine, Factors predicting response, Resilience, Pharmacologic augmentation strategies
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Also called Prozac
Fluoxetine will be administered at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response
PlaceboDrug
Also called Gelatin capsule
Placebo will be empty gelatin capsules that are identical in size and shape to active treatment
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Experimental | Receives Fluoxetine at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response Receives: Drug: Fluoxetine; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Fluoxetine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale
Measured: 12-Weeks
Secondary outcomes (1)
PTSD Symptom Checklist
Measured: Every follow-up encounter (weeks 2-32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startMar 2010
- Primary completionJun 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder, Combat-relatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TEMPVA Research Group, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- C.R.Darnall Army Medical Center, Central Texas Veterans Health Care System, VA Boston Healthcare System
- Investigators
- Paul B Hicks, M.D., Ph.D., Principal investigator, Central Texas Veterans Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633685
- Sponsor's protocol ID
- PR064845
- Other IDs
- PR064845
- Status last verified
- Feb 2010
- First submitted
- 4 Mar 2008
- Last updated
- 25 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Treatment Response to Fluoxetine in PTSD Following a Recent History of War Zone Stress Exposure
- ClinicalTrials.gov ID
- NCT00633685
- Acronym / sponsor ID
- PR064845
- Keywords
- Posttraumatic Stress Disorder, Fluoxetine, Factors predicting response, Resilience, Pharmacologic augmentation strategies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- TEMPVA Research Group, Inc.University, hospital or other
- Collaborators
- C.R.Darnall Army Medical Center, Central Texas Veterans Health Care System, VA Boston Healthcare System
- Study start
- Mar 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
While most soldiers exposed to the stresses of the war-zone exhibit psychological resilience, about one-fifth become psychological casualties of war. The fact that such a significant number of soldiers have difficulty adapting to life after war exposure suggests that we need to have well-defined treatments that are effective and cost-efficient. Currently, recommendations for first-line pharmacological management of Post-Traumatic Stress Disorder focus on the use of selective serotonin re-uptake inhibitors (SSRIs) such as fluoxetine. Despite this recommendation by the DoD/VA Clinical Practice Guidelines, there have not been any studies evaluating the effectiveness of these medications in patients that have recently been exposure to war-zone stressors. In fact, studies in Vietnam Era veterans have shown limited effectiveness of SSRIs for PTSD. In addition, there is very limited information available to understand the factors that influence whether a particular soldier will respond to treatment with an SSRI. This study is designed to determine whether fluoxetine is an effective treatment for PTSD and associated conditions in soldiers with recent war-zone exposure, as well as determine whether response to SSRIs is related to the severity of the trauma exposure and PTSD symptoms, psychological resilience, adequacy of social supports (family, extra-military and military), post-deployment stressors and life adversity, or the degree of any cognitive impairment.
After informed consent is given, fluoxetine (150 subjects) or placebo (150 subjects) will be administered for 12 weeks in doses from 20 mg daily up to 60 mg daily to active duty soldiers who are already receiving usual psychological care in the Resilience and Restoration Center of the Carl R. Darnall Army Medical Center at Ft. Hood. At the conclusion of this initial phase of the study, all participants will receive fluoxetine in doses up to 80 mg daily for an additional 20 weeks. All participants will be regularly monitored to determine changes in their PTSD symptoms. If a subject does not have at least a 50% improvement after being given 80 mg daily of fluoxetine for 4 weeks, then they will be randomly assigned to also receive either bupropion SR (150 mg daily) or buspirone (up to 40 mg daily) in an attempt to amplify the response to fluoxetine. Statistical analyses will be used to determine which factors provided the greatest influence on the response to these medication trials.
Each subject will be asked to receive a physical exam, give medical history information, and receive a diagnostic interview prior to participation in the study. After being randomly assigned to treatment, subjects will have interview or questionnaire assessments at weeks 2, 4, 6, 8, 12, 16, 20, 24, 28 and 32. Based solely on the degree of response as measured by the PTSD Checklist (a questionnaire that will be administered at each study visit), the dosage of study medication fluoxetine or placebo capsules will be adjusted by a pre-determined schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine | Experimental | Drug: Fluoxetine, Drug: PlaceboReceives Fluoxetine at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response |
| Placebo | Placebo comparator | Drug: Fluoxetine, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoxetineAlso: ProzacFluoxetine will be administered at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response | Drug | Fluoxetine, Placebo |
| PlaceboAlso: Gelatin capsulePlacebo will be empty gelatin capsules that are identical in size and shape to active treatment | Drug | Fluoxetine, Placebo |
Primary outcome
Clinician Administered PTSD Scale
Time frame: 12-Weeks
1 secondary outcome
PTSD Symptom Checklist
Time frame: Every follow-up encounter (weeks 2-32)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2010.
Related trials for Posttraumatic Stress Disorder, Combat-related
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul B Hicks, M.D., Ph.D. principal investigator
Central Texas Veterans Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluoxetine in people with Posttraumatic Stress Disorder, Combat-related, run by TEMPVA Research Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul B Hicks, M.D., Ph.D. (254-743-2643, paul.hicks@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (time frame: 12-Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2010.