RECRUITING

Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

Orexin Antagonism to Target Mechanisms of Suicide Risk: A Proof-of-Concept Clinical Trial

Quick Facts

Study Start:2025-09-01
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06854224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veteran
  2. * At least 18 years of age (up to 70 years)
  3. * Primary diagnosis of Major Depressive Disorder as determined by the study psychiatrist and confirmed by the Mini-International Neuropsychiatric Interview (MINI)
  4. * Lifetime suicide attempt history and suicidal ideation at baseline as determined by a score ≥2 on the Columbia-Suicide Severity Rating Scale (C-SSRS)
  1. * Clinically significant medical or neurological condition
  2. * Current use of strong CYP3A live enzymes or moderate CYP3A inhibitors or strong CYP3A inducers
  3. * Current use of digoxin
  4. * Currently pregnant, not using contraception, nursing, or trying to become pregnant
  5. * Active substance use disorder in the last six months, disorder, or current or past psychotic disorder, bipolar disorder, or obsessive-compulsive disorder
  6. * Severe traumatic brain injury
  7. * Imminent suicidal or homicidal risk
  8. * Free of unstable medical conditions or any contraindication to suvorexant (per FDA prescribing label) as determined by patient interview and review of available medical records.

Contacts and Locations

Study Contact

Marianne Goodman, MD
CONTACT
718-584-9000
Marianne.Goodman@va.gov
James Murrough, MD, PhD
CONTACT
212-585-4640
James.Murrough@va.gov

Study Locations (Sites)

James J. Peters Veterans Affairs Medical Center
The Bronx, New York, 10468
United States

Collaborators and Investigators

Sponsor: Marianne Goodman

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-01
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2025-09-01
Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

  • Suicide risk
  • Proof-of-concept clinical trial
  • Suvorexant
  • Orexin antagonist

Additional Relevant MeSH Terms

  • Suicide Risk
  • Major Depressive Disorder (MDD)