Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMarianne Goodman
About this 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 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)
Eligibility criteria
Qualifiers
Veteran
At least 18 years of age (up to 70 years)
Primary diagnosis of Major Depressive Disorder as determined by the study psychiatrist and confirmed by the Mini-International Neuropsychiatric Interview (MINI)
Lifetime suicide attempt history and suicidal ideation at baseline as determined by a score ≥2 on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Disqualifiers
Clinically significant medical or neurological condition
Current use of strong CYP3A live enzymes or moderate CYP3A inhibitors or strong CYP3A inducers
Current use of digoxin
Currently pregnant, not using contraception, nursing, or trying to become pregnant
Trial design
Treatments tested in this trial
- Suvorexant (dual orexin receptor antagonist)
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Marianne Goodman
Lead sponsor
Bronx Veterans Medical Research Foundation, Inc
Sponsor institution
James J. Peters Veterans Affairs Medical Center
Collaborator
Source ClinicalTrials.gov