At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 4 enrolled
Drug / intervention
Fluoxetinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Fluoxetine Treatment of Depression in Adults With Down Syndrome
In Brief
A Phase 4 clinical trial evaluating Fluoxetine for Down Syndrome and Depression. Completed, enrolled 4 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDown Syndrome, Depression
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2023202420252026
First PostedJul 2022
Enrollment StartDec 2022
Primary CompletionFeb 2024
TodayJul 2026
First PostedJul 14, 2022
Enrollment StartDec 5, 2022
Primary CompletionFeb 26, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.0 years ago
Interventions
Fluoxetinedrug
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.