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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%
Insomnia
4%
Nightmares
4%
Menstrual Cramps
4%
Silliness/Feeling too happy
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
1,740 Previous Clinical Trials
1,847,446 Total Patients Enrolled
83 Trials studying Depression
87,192 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what instances is Fluoxetine frequently prescribed?

"Fluoxetine has been demonstrated to be an effective remedy for myoclonus, unipolar depression, and obsessive-compulsive disorder."

Answered by AI

To what extent has Fluoxetine been examined through the use of medical experiments?

"Currently, 15 clinical trials for Fluoxetine are in progress. Of these studies, two have advanced to Phase 3 testing. Most of the research is based out of New Haven Connecticut; however, multiple other sites across the country are also hosting research on this medication."

Answered by AI

Who meets the qualifications for taking part in this medical experiment?

"This clinical trial seeks 224 participants afflicted with a hemorrhagic stroke, and must meet the following criteria: Between 18-85 years of age at admittance for subarachnoid hemorrhage stemming from ruptured cerebral aneurysm."

Answered by AI

To what extent has Fluoxetine been determined to be a hazard to individuals?

"Data surrounding Fluoxetine's safety is promising, as it has been rated a 2 on our 1-3 scale. This indicates that there is some evidence of security but none yet supporting its efficacy in this Phase 2 study"

Answered by AI

Is enrollment still open for this clinical investigation?

"Yes, according to clinicaltrials.gov this trial is currently recruiting participants for its study which began on March 1st 2019 and was last updated at the end of October 2022. 224 individuals are needed from a singular medical site."

Answered by AI

Is the minimum age requirement of this trial over twenty years old?

"The criteria for this clinical trial states that an eligible patient must be between the ages of 18 and 85. For those under 18, there are 233 studies available while persons above 65 have access to 2011 trials."

Answered by AI

What is the recruitment size for this medical trial?

"Affirmative. Primary source data from clinicaltrials.gov shows that this investigation, first posted on March 1st 2019, is currently recruiting 224 patients for one site. Last updates were made on October 31st 2022."

Answered by AI
~37 spots leftby Apr 2025