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Trial · NCT06854224

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

NCT06854224, Phase 2, Recruiting, Marianne Goodman

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial. Trials, record NCT06854224. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06854224

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial
NCT number
NCT06854224
Status
Recruiting
Phases
Phase 2
Enrollment
30 participants, estimated
Lead sponsor
Marianne Goodman
Conditions
Suicide Risk, Major Depressive Disorder (MDD)
Interventions
Suvorexant (dual orexin receptor antagonist)
First posted
2025-03-03
Last updated
2025-09-25

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryImplicit Association Tests (IATs)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.
SecondaryBuss-Perry Aggression QuestionnaireWeeks 1, 2, 3, 4, and 5
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).
SecondaryOvert Aggression Scale ModifiedWeeks 1, 2, 3, 4, and 5
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.
SecondaryPoint Subtraction Aggression ParadigmWeeks 1, 3, and 5
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.
SecondaryBarratt Impulsiveness ScaleWeeks 1, 2, 3, 4, and 5
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.
SecondaryBeck Scale for Suicidal IdeationWeeks 1, 2, 3, 4, and 5
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.
SecondaryColumbia Suicide Severity Rating ScaleWeeks 1, 2, 3, 4, and 5
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).
SecondaryGradual-Onset Continuous Performance TaskWeeks 1, 3, 5
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.
SecondaryEmotional Gradual Onset Continuous Performance TaskWeeks 1, 3, and 5
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.
OtherHamilton Depression ScaleWeeks 1, 2, 3, 4, and 5
The Hamilton Depression Scale (HAM-D) is a clinician-administered 17-item questionnaire assessing the severity of depressive symptoms. Each item measures a depressive symptom (e.g., feelings of guilt, anxiety somatic). Items are rated on a 5-point (0 to 4) or 3-point (0 to 2) scale.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
Implicit Association Test (IAT)Primary outcomeConductCognition
Continuous Performance TestSecondary outcomeConductCognition
Gradual-Onset Continuous Performance TaskSecondary outcomeConductCognition
Point Subtraction Aggression TaskSecondary outcomeConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06854224

GET https://conductscience.org/api/trials/v1/NCT06854224/registered