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Serotonin-Norepinephrine Reuptake Inhibitor

Open-Label Duloxetine Monotherapy in the Treatment of Posttraumatic 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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2008 Phase 4 trial • 339 Patients • NCT00422162
22%
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)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
2,679 Previous Clinical Trials
3,465,733 Total Patients Enrolled
Jose M Canive, M.D.Principal InvestigatorNew Mexico VA Healthcare System
~1 spots leftby Dec 2025
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