NCT05458479

Fluoxetine Treatment of Depression in Down Syndrome

Fluoxetine Treatment of Depression in Adults With Down Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to do a preliminary assessment of whether fluoxetine is effective, safe, and tolerable for the treatment of depression in adults with Down syndrome.

Detailed description

After being informed about the study and potential risks, all patients or their legal guardians giving written informed consent will be screened for study eligibility. Patients who meet the eligibility requirements will participate in a 16-week, flexibly-dosed, open-label trial of fluoxetine. The dose of fluoxetine will be adjusted over the first 12 weeks of the study and a stable dose will be maintained for the final four weeks of the trial. Adverse effects will be reviewed at each visit and standardized measures of depression will be conducted at weeks 4, 8, 12, and 16.

Conditions

• Down Syndrome
• Depression

Interventions

Type	Name	Description
DRUG	Fluoxetine	All participants in the study will receive open-label treatment with orally administered fluoxetine for the full duration of the 16-week trial. Fluoxetine is a selective serotonin reuptake inhibitor. It is approved for the management of major depressive disorder in adults.

Timeline

• Start date: 2022-12-05
• Primary completion: 2024-02-26
• Completion: 2024-02-26
• First posted: 2022-07-14
• Last updated: 2025-03-30
• Results posted: 2025-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study