Fluoxetine for Poststroke Depression

Recruiting in Palo Alto (17 mi)

Overseen byMichael Levitt, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Washington

Prior Safety Data

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.

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.

I am between 18 and 85 years old.

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.

See 4 more

Treatment Details

Interventions

Fluoxetine (Selective Serotonin Reuptake Inhibitor)
Placebo (Behavioural Intervention)

Trial OverviewThe 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

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.