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NCT05450432 · ClinicalTrials.gov registry record · Phase 4
Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression
A Phase 4 study of Major Depressive Disorder, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05450432: Recruiting Phase 4 study of Major Depressive Disorder, sponsored by Massachusetts General Hospital.
NCT05450432 is a Phase 4 study of Major Depressive Disorder that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 100 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05450432, a Phase 4 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit. Eligible patients who provided informed consent will be enrolled in the study that will include a eight IV ketamine treatments, 13 esketamine treatment visits, seven long assessment visits, five short assessment visits, and daily surveys. The study will examine the feasibility, tolerability, and efficacy of repeated IV ketamine followed by esketamine, as well as predictors of treatment response.
Primary Outcome
For examining the feasibility of treatment with ketamine and esketamine, descriptive analyses will be conducted to assess participants' retention across study visits.
Conditions Studied
Interventions
- DRUG Ketamine
- DRUG Esketamine
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-10-13 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 4 |
What NCT05450432 shows while recruiting
NCT05450432 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Ketamine is the first listed.
NCT05450432 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05450432 about?
NCT05450432 is a clinical study titled "Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression". The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an ...
What is the current status of trial NCT05450432?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2022-10-13. Estimated completion is 2026-06-01.
What conditions does trial NCT05450432 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT05450432?
The interventions under investigation include: Ketamine (DRUG), Esketamine (DRUG).
Who is sponsoring clinical trial NCT05450432?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05450432 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05450432's enrollment target sits among peer trials
100 132nd of 282 higher than 145 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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
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