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Serotonin-Norepinephrine Reuptake Inhibitor

A for Depression

Phase 4
Waitlist Available
Led By Claudio N Soares, MD, PhD
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

The main objective of this study is to characterize a range of brain activation symptoms associated with major depression in peri- and post-menopausal women. Also, assessing brain activation before and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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
The effects of response to treatment with duloxetine on brain structure and activation in subjects (peri- and postmenopausal women with MDD).
Secondary outcome measures
Changes in brain activation in remitters versus non-remitters after treatment with duloxetine (remission of depression defined MADRS total score <10 at study end).
Correlations between changes in brain activation and changes from baseline to study end and menopausal symptoms, depressive symptoms, cognition, quality of life, and clinical global impression (improvement and severity).

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: AExperimental Treatment1 Intervention
Use of duloxetine, flexible dose (60-120mg/day) for 8 weeks, following a 2-week placebo lead-in phase
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?

Eli Lilly and CompanyIndustry Sponsor
2,624 Previous Clinical Trials
3,216,727 Total Patients Enrolled
66 Trials studying Depression
277,034 Patients Enrolled for Depression
McMaster UniversityOTHER
890 Previous Clinical Trials
2,605,362 Total Patients Enrolled
35 Trials studying Depression
5,664 Patients Enrolled for Depression
Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,896 Total Patients Enrolled
2 Trials studying Depression
260 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
Duloxetine for Major Depression in Peri-/Postmenopausal Women
2009. "Duloxetine for Major Depression in Peri-/Postmenopausal Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00889369.
All > Major Depressive Disorder
~4 spots leftby May 2025
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