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NCT06854224 · ClinicalTrials.gov registry record · Phase 2
Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial
A Phase 2 study of Major Depressive Disorder (MDD) and Suicide Risk, sponsored by Marianne Goodman.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06854224 is a Phase 2 study of Major Depressive Disorder (MDD) and Suicide Risk that is actively recruiting participants, run by Marianne Goodman. The registered enrollment target is 30 participants, below the 157-participant average among 22 other Major Depressive Disorder (MDD) trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06854224, a Phase 2 study of Major Depressive Disorder (MDD) and Suicide Risk, is actively recruiting participants, sponsored by Marianne Goodman.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this proof-of-concept clinical trial is to evaluate the initial safety, feasibility, and tolerability of the orexin mixed antagonist suvorexant in a sample of veteran adults with Major Depressive Disorder and elevated suicide risk. The main question it aims to answer is: Is Suvorexant safe, feasible, and tolerable for participants? Participants will: * Take Surovexant every day for four weeks (10mg in the first two weeks and 20mg in the second two weeks) * Visit the medical center at the beginning of the study (week 1), after taking Suvorexant for two weeks (week 3) and following the full Suvorexant dose (week 5) for in-person assessments. * Fill out self-report assessments (remotely) at week 2 (after one week of Suvorexant) and week 4 (after three weeks of Surovexant)
Conditions Studied
Interventions
- DRUG Suvorexant (dual orexin receptor antagonist)
Study Locations (1)
New York
- James J. Peters Veterans Affairs Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-09-01 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06854224
The ClinicalTrials.gov registry entry for NCT06854224 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 157-participant average among 22 other Major Depressive Disorder (MDD) trials with a reported enrollment target (81% lower). The listed sponsor is Marianne Goodman, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Major Depressive Disorder (MDD) appearing as the primary indexed condition, and to 1 intervention - of which Suvorexant (dual orexin receptor antagonist) is the first listed.
NCT06854224 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06854224 about?
NCT06854224 is a clinical study titled "Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial". The goal of this proof-of-concept clinical trial is to evaluate the initial safety, feasibility, and tolerability of the orexin mixed antagonist suvorexant in a sample of veteran adults with Major Depressive Disorder and elevated suicide risk. The main question it aims to answer is: Is Suvorexant sa...
What is the current status of trial NCT06854224?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2025-09-01. Estimated completion is 2027-07-01.
What conditions does trial NCT06854224 study?
This clinical trial studies the following conditions: Major Depressive Disorder (MDD), Suicide Risk.
What interventions are being tested in trial NCT06854224?
The interventions under investigation include: Suvorexant (dual orexin receptor antagonist) (DRUG).
Who is sponsoring clinical trial NCT06854224?
This trial is sponsored by Marianne Goodman, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06854224 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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