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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 up to 5 years
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group

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 ~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 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

Awards & Highlights

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

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
2,667 Previous Clinical Trials
3,228,421 Total Patients Enrolled
66 Trials studying Depression
277,034 Patients Enrolled for Depression
McMaster UniversityOTHER
916 Previous Clinical Trials
2,615,189 Total Patients Enrolled
36 Trials studying Depression
5,834 Patients Enrolled for Depression
Hamilton Health Sciences CorporationLead Sponsor
377 Previous Clinical Trials
340,330 Total Patients Enrolled
2 Trials studying Depression
260 Patients Enrolled for Depression
~4 spots leftby Nov 2025
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