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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether fluoxetine, a medication commonly used for depression, can prevent depression in individuals who have survived aneurysmal subarachnoid hemorrhage (aSAH). Participants will receive either fluoxetine or a placebo (a harmless pill with no active ingredient) for one year to determine if fluoxetine reduces the risk of developing depression after this type of stroke. Suitable candidates for this trial include those who have experienced a stroke due to a burst brain aneurysm and are not currently receiving treatment for depression or related conditions. As a Phase 2 trial, this research aims to assess fluoxetine's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fluoxetine has been tested in stroke patients to assess its impact on depression. Some studies found that fluoxetine reduced depression in these patients, but side effects occurred. In one study, participants taking fluoxetine experienced more broken bones and hyponatremia, a condition of low sodium levels in the blood.

These findings are based on research where fluoxetine was used for various conditions, not just stroke. The FDA has already approved it for treating depression, providing some information about its safety. Prospective trial participants should understand both the potential benefits and risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for poststroke depression?

Fluoxetine is unique because it offers a potential new use for an existing antidepressant specifically targeting poststroke depression. Most treatments for poststroke depression involve standard antidepressants like SSRIs, including sertraline and citalopram, which can take several weeks to show effects. However, fluoxetine, known for its use in treating major depressive disorder, could provide more targeted relief by possibly affecting neuroplasticity, which is the brain's ability to adapt and reorganize itself—an exciting possibility for stroke recovery. Researchers are keen to see if fluoxetine can offer faster or more effective symptom relief, potentially improving both mood and cognitive function in stroke survivors.

What evidence suggests that fluoxetine might be an effective treatment for poststroke depression?

Research shows that fluoxetine, which participants in this trial may receive, can help reduce depression in people who have had a stroke. Some studies found that fluoxetine lowers the risk of developing depression after a stroke. It also helps with anxiety and improves thinking and movement. Although not all studies found significant improvement in overall disability, fluoxetine did aid mood-related symptoms. Overall, fluoxetine appears promising in preventing depression for stroke survivors. ^{1 4 6 7 8}

Who Is on the Research Team?

Michael Levitt, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2782749

Depression Outcomes Among Patients Treated With ... Fluoxetine did not improve functional outcomes, but FOCUS and EFFECTS found that fluoxetine reduced the prevalence of depression. The pragmatic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9333390/

Safety and Efficacy of SSRIs in Improving Poststroke Recovery Our study showed that SSRIs are effective in preventing and treating depression, and improving anxiety, motor function, cognitive function, and dependence in ...

3. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.neuropsych.21090231

Poststroke Depression: An Update | The Journal of ... The primary outcome was functional status, measured with the mRS, at 6 months. Fluoxetine was not better than placebo in reducing disability ...

4. ahajournals.org ahajournals.org/doi/10.1161/str.0000000000000113

Poststroke Depression: A Scientific Statement for ... Treatment with fluoxetine was associated with lower PSD occurrence rates and improvement in motor recovery in 1 RCT. Further research is needed ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16306470/

Fluoxetine treatment in poststroke depression, emotional ... Fluoxetine significantly improved PSEI and PSAP, whereas no definitive improvement of PSD was found. Improvement of PSAP was noted even at 3 months after the ...

6. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.121.034705

Effects of Fluoxetine on Outcomes at 12 Months After Acute ... 20 mg fluoxetine once daily for 6 months after acute stroke did not improve functional outcome but reduced depression and increased fractures and hyponatremia ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8329781/

Depression Outcomes Among Patients Treated With ... FOCUS, the largest fluoxetine trial of individuals with stroke published to date, reported that depression affected 17% of participants treated ...

8. psychiatrist.com psychiatrist.com/jcp/fluoxetine-for-stroke-a-mixed-bag-of-outcomes/

Fluoxetine for Stroke: A Mixed Bag of Outcomes FOCUS (by 3.8%) and EFFECTS (by 3.6%) but not AFFINITY found a significantly lower risk of poststroke depression with fluoxetine. In all 3 ...