Fluoxetine for Poststroke Depression

Overseen By Do Lim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Washington

Must not be taking: Antidepressants

Disqualifiers: Non-English, Pregnancy, Active psychosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

224 Participants Needed

Trial Summary

What is the purpose of this trial?

A double-blinded placebo-controlled randomized trial to evaluate the effect of preventative treatment of depression in survivors of aneurysmal subarachnoid hemorrhage (aSAH), a type of stroke.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already receiving therapy for depression or related mental health issues.

What data supports the effectiveness of the drug fluoxetine for poststroke depression?

Research shows that fluoxetine, a type of antidepressant, can help prevent depression after a stroke. In one study, fewer people developed depression when taking fluoxetine compared to those taking a placebo (a dummy pill). ^{1 2 3 4 5}

Is fluoxetine safe for humans?

Fluoxetine, commonly known as Prozac, is generally considered safe for humans, but it may increase the risk of seizures. It has been studied for various conditions, including poststroke recovery, and while it can help with depression and motor function, its safety profile is similar to other SSRIs (a type of antidepressant). ^{2 6 7 8 9}

How does the drug fluoxetine differ from other treatments for poststroke depression?

Fluoxetine is unique for poststroke depression because it is a selective serotonin reuptake inhibitor (SSRI) that not only helps with depression but may also improve motor recovery and emotional disturbances after a stroke, unlike other treatments that might not address these additional issues. ^{2 3 4 7 8}

Research Team

Michael Levitt, MD

Principal Investigator

University of Washington

Eligibility Criteria

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.

Inclusion Criteria

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

Only patients who provide informed consent will be included.

Exclusion Criteria

I speak and understand English.

Pregnant patients or patients considering pregnancy during the trial period at the time of consent will be excluded.

I do not have any health conditions that prevent me from taking fluoxetine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either fluoxetine or placebo for the preventative treatment of depression

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Fluoxetine
• Placebo

Trial Overview 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).

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year.

Group II: Placebo Placebo Group 1 Intervention

Patients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Fluoxetine for Post-Ischemic Stroke Depression in Tanzania. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Early fluoxetine treatment of post-stroke depression--a three-month double-blind placebo-controlled study with an open-label long-term follow up. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Fluoxetine in early poststroke depression: a double-blind placebo-controlled study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Preventing poststroke depression: a 12-week double-blind randomized treatment trial and 21-month follow-up. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Fluoxetine vs placebo for depressive symptoms after stroke: failed randomised controlled trial. [2013]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Is Fluoxetine Good for Subacute Stroke? A Meta-Analysis Evidenced From Randomized Controlled Trials. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Does the Initiation of Fluoxetine Postacute Stroke Result in Improved Functional Recovery?: A Critically Appraised Topic. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Fluoxetine treatment in poststroke depression, emotional incontinence, and anger proneness: a double-blind, placebo-controlled study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of SSRIs in Improving Poststroke Recovery: A Systematic Review and Meta-Analysis. [2022]