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Serotonin-Norepinephrine Reuptake Inhibitor
1 for Post-Traumatic Stress Disorder
Phase 3
Waitlist Available
Led By Jose M Canive, M.D.
Research Sponsored by Canive, Jose M., M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 1, 2, 4, 8, & 12
Awards & highlights
Study Summary
The purpose of this study is to determine whether Duloxetine (Cymbalta®) is an effective treatment in reducing the symptoms of Posttraumatic Stress Disorder (PTSD).
Eligible Conditions
- Post-Traumatic Stress Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 1, 2, 4, 8, & 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 1, 2, 4, 8, & 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PTSD Symptoms will be assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS)
Secondary outcome measures
Visual Analog Scale for Pain (VAS)
Side effects data
From 2008 Phase 4 trial • 339 Patients • NCT0042216222%
Nausea
16%
Headache
5%
Hyperhidrosis
5%
Constipation
5%
Dry mouth
4%
Diarrhoea
2%
Insomnia
2%
Suicidal ideation
2%
Nasopharyngitis
2%
Tremor
2%
Suicide attempt
1%
Irritability
1%
Self injurious behaviour
1%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duloxetine (60 mg)
Duloxetine (120 mg)
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Open-label Study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duloxetine
FDA approved
Find a Location
Who is running the clinical trial?
Canive, Jose M., M.D.Lead Sponsor
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,497 Total Patients Enrolled
Jose M Canive, M.D.Principal InvestigatorNew Mexico VA Healthcare System
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What site did they apply to?
New Mexico VA Health Care System
What portion of applicants met pre-screening criteria?
Met criteria
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