Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05458479 · ClinicalTrials.gov registry record · Phase 4
Fluoxetine Treatment of Depression in Down Syndrome
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT05458479: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT05458479 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05458479, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7 (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7= very much worse), with lower scores indicating improvement (1=very much improved; 2=much improved). In this study, the CGI-I will be focused on the treatment target of depression symptom severity.
Interventions
- DRUG Fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2022-12-05 |
| Est. Completion | 2024-02-26 |
| Phase | Phase 4 |
What the finished NCT05458479 record still lists
NCT05458479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Fluoxetine is the first listed.
NCT05458479 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05458479 about?
NCT05458479 is a clinical study titled "Fluoxetine Treatment of Depression in Down Syndrome". 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.
What is the current status of trial NCT05458479?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2022-12-05. Estimated completion is 2024-02-26.
What interventions are being tested in trial NCT05458479?
The interventions under investigation include: Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT05458479?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05458479's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI