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Fluoxetine for Poststroke Depression

Phase 2
Recruiting
Led By Michael Levitt, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients admitted for subarachnoid hemorrhage from a ruptured cerebral aneurysm will be included.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial looks at whether treating depression can help people who have had a certain type of stroke.

Who is the study for?
This trial is for individuals aged 18-85 who have survived a hemorrhagic stroke due to a ruptured cerebral aneurysm and can give informed consent. It's not for those with active psychosis, in custody, non-English speakers, pre-existing depression treatment, cognitive impairments preventing consent, fluoxetine contraindications or pregnant women.Check my eligibility
What is being tested?
The study tests if Fluoxetine prevents depression after surviving an aneurysmal subarachnoid hemorrhage (a type of stroke). Participants are randomly assigned to receive either Fluoxetine or a placebo without knowing which one they're getting (double-blinded).See study design
What are the potential side effects?
Fluoxetine may cause nausea, headaches, sleep disturbances, anxiety, and sexual dysfunction among other side effects. The severity varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was admitted for bleeding in the brain from a burst blood vessel.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Depression
Secondary outcome measures
Anxiety
Fatigue
Function
+3 more

Side effects data

From 2012 Phase 4 trial • 43 Patients • NCT00245635
8%
Stomach Pains
8%
Weight Loss
4%
Nausea
4%
Trouble Sleeping
4%
Nightmares
4%
Silliness/Feeling too happy
4%
Emotional
4%
Menstrual Cramps
4%
Insomnia
4%
Suicidal Behavior
4%
Lit Paper on Fire
4%
Fatigue
4%
Decreased Appetite
4%
Sweating
4%
Agitated/Restlessness
4%
Dry Mouth
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Fluoxetine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year.
Group II: PlaceboPlacebo Group1 Intervention
Patients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluoxetine
FDA approved

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,752 Previous Clinical Trials
1,840,273 Total Patients Enrolled
84 Trials studying Depression
87,255 Patients Enrolled for Depression
Michael Levitt, MDPrincipal InvestigatorUniversity of Washington

Media Library

Fluoxetine Clinical Trial Eligibility Overview. Trial Name: NCT03826875 — Phase 2
Depression Research Study Groups: Treatment, Placebo
Depression Clinical Trial 2023: Fluoxetine Highlights & Side Effects. Trial Name: NCT03826875 — Phase 2
Fluoxetine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03826875 — Phase 2
~36 spots leftby Jun 2025
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