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Serotonin-Norepinephrine Reuptake Inhibitor

Duloxetine treatment for Depression

Phase 4
Waitlist Available
Research Sponsored by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 20-50 Primary diagnosis of major depression Ability to give informed consent
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

Major depression is accompanied by cognitive changes as well as alterations in multiple physical functions. The inflammatory system is altered generally toward a pro-inflammatory state. Antidepressants are associated with a decrease in this proinflammatory state. This study aims to generate pilot data concerning a possible link between cognition, inflammation and response to treatment. The cognitive function of subjects with major depression will be tested before and after treatment with duloxetine. Inflammatory markers will be measured at both time points.

Eligible Conditions
  • Depression

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognitive function measured by CANTAB
Secondary outcome measures
Allostatic load
pain inhibition

Side effects data

From 2012 Phase 4 trial • 291 Patients • NCT01118780
11%
Nausea
11%
Headache
9%
Constipation
8%
Dizziness
7%
Dry mouth
6%
Somnolence
5%
Diarrhoea
4%
Abdominal pain upper
4%
Fall
4%
Decreased appetite
4%
Pruritus
3%
Vertigo
3%
Hyperhidrosis
2%
Nasopharyngitis
1%
Hypertensive crisis
1%
Angina pectoris
1%
Back pain
1%
Insomnia
1%
Large intestinal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duloxetine
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Duloxetine treatmentExperimental Treatment1 Intervention
Subjects with major depression will be entered into the trial and treated with open label duloxetine
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?

Centre de Recherche de l'Institut Universitaire en santé Mentale de MontréalLead Sponsor
12 Previous Clinical Trials
981 Total Patients Enrolled
1 Trials studying Depression
40 Patients Enrolled for Depression
Eli Lilly and CompanyIndustry Sponsor
2,610 Previous Clinical Trials
3,200,413 Total Patients Enrolled
66 Trials studying Depression
277,084 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Inflammatory Markers and Cognitive Function in Major Depression
Smadar Valerie Tourjman 2011. "Inflammatory Markers and Cognitive Function in Major Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01391221.
All > Major Depressive Disorder
~1 spots leftby Apr 2025
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