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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
Must not have
Non-English speaking patients will be excluded.
Patients with medical contraindications to fluoxetine therapy will be excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

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.
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).
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
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I was admitted for bleeding in the brain from a burst blood vessel.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I speak and understand English.
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I do not have any health conditions that prevent me from taking fluoxetine.
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I am not currently receiving treatment for depression or any related mental health issues.
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I can understand and agree to the study because my thinking is clear.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Depression
Secondary study objectives
Anxiety
Fatigue
Function
+3 more

Side effects data

From 2012 Phase 4 trial • 43 Patients • NCT00245635
8%
Weight Loss
8%
Stomach Pains
4%
Menstrual Cramps
4%
Silliness/Feeling too happy
4%
Trouble Sleeping
4%
Nausea
4%
Insomnia
4%
Nightmares
4%
Emotional
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
1,791 Previous Clinical Trials
1,905,282 Total Patients Enrolled
85 Trials studying Depression
87,645 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
~34 spots leftby Sep 2025
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