Suicide RiskPhase 2NCT06854224
Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial
A Phase 2 study testing Suvorexant (dual orexin receptor antagonist) in people with Suicide Risk and Major Depressive Disorder (MDD), run by Marianne Goodman at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Suicide Risk, Major Depressive Disorder (MDD)
- What is being tested?
- Suvorexant (dual orexin receptor antagonist)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 1 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
- Active substance use disorder in the last six months, disorder, or current or past psychotic disorder, bipolar disorder, or obsessive-compulsive disorder
- Severe traumatic brain injury
- Imminent suicidal or homicidal risk
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, 10468
About this study
Official title: Orexin Antagonism to Target Mechanisms of 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 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
- Suicide Risk, Major Depressive Disorder (MDD)
- Being tested
- Suvorexant (dual orexin receptor antagonist)
- Keywords
- Suicide risk, Proof-of-concept clinical trial, Suvorexant, Orexin antagonist
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suvorexant (dual orexin receptor antagonist)Drug
Veteran patients with Major Depressive Disorder and elevated risk of suicide will receive the FDA-approved drug Suvorexant (brand name: Belsomra), a dual orexin receptor antagonist, for four weeks. Participants will take 10mg of Surovexant nightly for the first two weeks and 20mg of Surovexant nightly for the second two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Suvorexant group | Experimental | Veteran patients with Major Depressive Disorder and elevated risk of suicide will receive the FDA-approved drug Suvorexant (brand name: Belsomra), a mixed Orexin antagonist, for four weeks. Participants will take 10mg of Surovexant nightly for the first two weeks and 20mg of Surovexant nightly for the second two weeks. Receives: Drug: Suvorexant (dual orexin receptor antagonist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implicit Association Tests (IATs)
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 associations. This study uses two variations of the IAT, a suicide-related IAT and a Escape-Me IAT to determine the extent to which participants associate suicide-related and escape-related constructs with the self.
Measured: Weeks 1, 3, and 5
Secondary outcomes (8)
Buss-Perry Aggression Questionnaire
The Buss-Perry Aggression Questionnaire is a 20-item self-report questionnaire assessing four dimensions of aggression: physical aggression, verbal aggression, anger, and hostility. Participants indicate how well each item describes them on a 5-point scale ranging from 1 (Not at all like me) to 5 (Very much like me).
Measured: Weeks 1, 2, 3, 4, and 5
Overt Aggression Scale Modified
The Overt Aggression Scale Modified (OAS-M) is a clinician-administered interview of aggressive behavior. Participants are asked about "outbursts of anger" (reactive aggression) in the past week. The OAS-M is strongly related to measures of anger and differentiates between participants with and without intermittent explosive disorder, supporting its validity as a measure of reactive aggression.
Measured: Weeks 1, 2, 3, 4, and 5
Point Subtraction Aggression Paradigm
The Point Subtraction Aggression Paradigm (PSAP) is a laboratory-based assessment of reactive aggression in which participants play a competitive computer game against a fictional opponent to obtain points that coincide with a monetary reward. The PSAP can be administered virtually through Inquisit Web, a software designed to facilitate virtual research experiments.
Measured: Weeks 1, 3, and 5
Barratt Impulsiveness Scale
The Barratt Impulsiveness Scale (BIS-11) is a 30-item self-report questionnaire assessing the personality/behavioral construct of impulsiveness. It includes six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness). Participants rate each item on a 4-point scale ranging from 1 (Rarely/Never) to 4 (Almost Always/Always). Total scores can range from 30 to 120.
Measured: Weeks 1, 2, 3, 4, and 5
Beck Scale for Suicidal Ideation
The Beck Scale for Suicidal Ideation (BSSI) is a 21-item self-report questionnaire assessing suicidal thinking that helps identify individuals at risk. It also measures a broad spectrum of suicide-related attitudes and behaviors. The first five items are often used as the screener, where participants are directed to item 20 if they score 0 on these items. The overall score is computed by totaling up the scores on the first 19 items. Each item is rated from 0 to 2. Scores range from 0 to 38, with a higher score indicating a higher level of suicide ideation.
Measured: Weeks 1, 2, 3, 4, and 5
Columbia Suicide Severity Rating Scale
The Columbia Suicide Severity Rating Scale (C-SSRS) is a clinician-administered questionnaire assessing suicidal ideation and behavior with four subscales: ideation severity (five types of ideation of increasing severity), intensity of ideation (Frequency, Duration, Controllability, Deterrents, and Reasons for Ideation), suicidal behavior (4 types of suicidal behaviors - actual, interrupted, aborted attempts and preparatory behaviors - and the total number), and behavior lethality (For suicide attempts or non-suicidal self-injurious behavior).
Measured: Weeks 1, 2, 3, 4, and 5
Gradual-Onset Continuous Performance Task
The gradCPT task is a continuous performance task designed to measure sustained attention and response inhibition. It involves monitoring a continuous stream of natural scenes from two categories-cities and mountains-with a 9:1 ratio. Participants respond either to the frequent or rare category, yielding a response rate of either 90% or 10%. The task is associated with substantial and stable individual differences, with performance correlating significantly with network connectivity both during task performance and in resting states. The gradCPT task is an important new paradigm in attention research, providing insights into the neural network of sustained attention and the role of response inhibition in performance.
Measured: Weeks 1, 3, 5
Emotional Gradual Onset Continuous Performance Task
The Emotional Gradual Onset Continuous Performance Task (emogradCPT), is used to characterize the impact of emotional distractors (background images) on the ability to sustain attention during an emotionally neutral task (digit discrimination task). The emogradCPT consists of digits that gradually fade from one to the next every 800ms, with participants responding to most digits (90% of trials) and withholding responses to rare digits (10% of trials). The task is associated with substantial and stable individual differences, with performance correlating significantly with network connectivity both during task performance and in resting states. The emogradCPT task is an important new paradigm in attention research, providing insights into the neural network of sustained attention.
Measured: Weeks 1, 3, and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Sep 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marianne Goodman
- Sponsor type
- University, hospital or other
- Collaborators
- James J. Peters Veterans Affairs Medical Center
- Responsible party
- Sponsor-investigator, Marianne Goodman, Bronx Veterans Medical Research Foundation, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854224
- Sponsor's protocol ID
- 1851192
- Status last verified
- Sep 2025
- First submitted
- 25 Feb 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orexin Antagonism to Target Mechanisms of Suicide Risk: A Proof-of-Concept Clinical Trial
- ClinicalTrials.gov ID
- NCT06854224
- Acronym / sponsor ID
- 1851192
- Conditions
- Suicide Risk, Major Depressive Disorder (MDD)
- Keywords
- Suicide risk, Proof-of-concept clinical trial, Suvorexant, Orexin antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marianne GoodmanUniversity, hospital or other
- Collaborators
- James J. Peters Veterans Affairs Medical Center
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suvorexant group | Experimental | Drug: Suvorexant (dual orexin receptor antagonist)Veteran patients with Major Depressive Disorder and elevated risk of suicide will receive the FDA-approved drug Suvorexant (brand name: Belsomra), a mixed Orexin antagonist, for four weeks. Participants will take 10mg of Surovexant nightly for the first two weeks and 20mg of Surovexant nightly for the second two weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
- Active substance use disorder in the last six months, disorder, or current or past psychotic disorder, bipolar disorder, or obsessive-compulsive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suvorexant (dual orexin receptor antagonist)Veteran patients with Major Depressive Disorder and elevated risk of suicide will receive the FDA-approved drug Suvorexant (brand name: Belsomra), a dual orexin receptor antagonist, for four weeks. Participants will take 10mg of Surovexant nightly for the first two weeks and 20mg of Surovexant nightly for the second two weeks. | Drug | Suvorexant group |
Primary outcome
Implicit Association Tests (IATs)
Time frame: Weeks 1, 3, and 5
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 associations. This study uses two variations of the IAT, a suicide-related IAT and a Escape-Me IAT to determine the extent to which participants associate suicide-related and escape-related constructs with the self.
8 secondary outcomes
Buss-Perry Aggression Questionnaire
Time frame: Weeks 1, 2, 3, 4, and 5
Overt Aggression Scale Modified
Time frame: Weeks 1, 2, 3, 4, and 5
Point Subtraction Aggression Paradigm
Time frame: Weeks 1, 3, and 5
Barratt Impulsiveness Scale
Time frame: Weeks 1, 2, 3, 4, and 5
Beck Scale for Suicidal Ideation
Time frame: Weeks 1, 2, 3, 4, and 5
Columbia Suicide Severity Rating Scale
Time frame: Weeks 1, 2, 3, 4, and 5
Gradual-Onset Continuous Performance Task
Time frame: Weeks 1, 3, 5
Emotional Gradual Onset Continuous Performance Task
Time frame: Weeks 1, 3, and 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Suvorexant (dual orexin receptor antagonist) in people with Suicide Risk and Major Depressive Disorder (MDD), run by Marianne Goodman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianne Goodman, MD (718-584-9000 ext. 5188, Marianne.Goodman@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implicit Association Tests (IATs) (time frame: Weeks 1, 3, and 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.