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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: Recruiting Phase 2 study of Major Depressive Disorder (MDD) and Suicide Risk, sponsored by Marianne Goodman.

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. According to ClinicalTrials.gov, the official US trial registry.

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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)

Primary Outcome

Implicit Association Tests ( IATs) use reaction time (RT) to capture automatic, implicit processes to gauge implicit self-identification with a construct of interest. Participants classify stimuli presented in the center of the screen into categories. The category labels are located on the left and right of the screen and participants classify stimuli by selecting keys corresponding to the left or right. RTs are measured as participants complete this task thereby gauging implicit mental associat

Interventions

  • DRUG Suvorexant (dual orexin receptor antagonist)

Study Locations (1)

New York

  • James J. Peters Veterans Affairs Medical Center - The Bronx

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2025-09-01
Est. Completion 2027-07-01
Phase Phase 2
Marianne Goodman

1 total trials

What NCT06854224 shows while recruiting

NCT06854224 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 157-participant average among 22 other Major Depressive Disorder (MDD) trials with a reported enrollment target (81% lower).

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 a single indexed study location in 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.

Similar trials for Major Depressive Disorder (MDD)

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 NCT06854224's enrollment target sits among peer trials

30 17th of 22 higher than 6 of 22 other Major Depressive Disorder (MDD) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Major Depressive Disorder (MDD) 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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Source: ClinicalTrials.gov NCT06854224, the US trial registry maintained by the National Library of Medicine. NCT06854224 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.