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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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
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 belowSelect...
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:Select...
I speak and understand English.
Select...
I do not have any health conditions that prevent me from taking fluoxetine.
Select...
I am not currently receiving treatment for depression or any related mental health issues.
Select...
I can understand and agree to the study because my thinking is clear.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 moreSide effects data
From 2012 Phase 4 trial • 43 Patients • NCT002456358%
Weight Loss
8%
Stomach Pains
4%
Silliness/Feeling too happy
4%
Trouble Sleeping
4%
Nausea
4%
Menstrual Cramps
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
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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
1,812 Previous Clinical Trials
1,913,577 Total Patients Enrolled
86 Trials studying Depression
87,655 Patients Enrolled for Depression
Michael Levitt, MDPrincipal InvestigatorUniversity of Washington
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak and understand English.I was admitted for bleeding in the brain from a burst blood vessel.I do not have any health conditions that prevent me from taking fluoxetine.I am not currently receiving treatment for depression or any related mental health issues.I am between 18 and 85 years old.I can understand and agree to the study because my thinking is clear.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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