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Fluoxetine for Poststroke Depression

Harborview Medical Center, Seattle, WA

Targeting 2 different conditionsFluoxetine +1 morePhase 2RecruitingLed by Michael Levitt, MDResearch 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.

Patients 18-85 years of age aged 18 years and older will be included.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up1 year

Awards & highlights

Study Summary

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

Eligible Conditions

Depression
Hemorrhagic Stroke

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

People who have been admitted to the hospital with a certain type of bleeding in the brain from a burst blood vessel will be included.

Select...

People who are 18 years old or older can participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Stomach Pains

Weight Loss

Trouble Sleeping

Nightmares

Insomnia

Silliness/Feeling too happy

Lit Paper on Fire

Emotional

Menstrual Cramps

Suicidal Behavior

Nausea

Fatigue

Decreased Appetite

Sweating

Agitated/Restlessness

Dry Mouth

Headache

100%

80%

60%

40%

20%

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

2005

Completed Phase 4

~4600

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,696 Previous Clinical Trials

1,687,690 Total Patients Enrolled

82 Trials studying Depression

87,171 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

Recent research and studies

clinicaltrials.govStudy

Poststroke Depression in Hemorrhagic Stroke

Michael Robert Levitt, MD 2019. "Poststroke Depression in Hemorrhagic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03826875.

All > Major Depressive Disorder > Prozac