- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07438912
Mind After Midnight (MaM)
The Mind After Midnight: Mechanistic Examination of Nocturnal Wakefulness as a Suicide Risk Factor
Study Overview
Status
Intervention / Treatment
Detailed Description
Suicide risk is elevated during the biological night, particularly between 2:00 and 4:00 AM. Observational and epidemiologic data suggest that nocturnal wakefulness is associated with increased negative affect, impaired decision-making, and greater suicidal ideation. The "Mind After Midnight" hypothesis proposes that wakefulness during the biological night exposes individuals to a combination of circadian vulnerability and homeostatic sleep pressure that contributes to emotional and cognitive dysregulation.
This study will recruit approximately 90 adults with a history of suicidal ideation in the past six months. Participants will complete both home-based and laboratory-based procedures. Laboratory assessments will evaluate mood, hopelessness, suicidal ideation, impulsivity, and decision-making at different times of day, including 2:00-4:00 AM. To examine the role of homeostatic sleep pressure, participants will complete late-night assessments under two conditions: (1) high sleep pressure (remaining awake until 2:00 AM) and (2) low sleep pressure (sleeping and being awakened at 2:00 AM). Circadian factors will be assessed using behavioral measures and physiologic markers, including melatonin.
The goal of the study is to experimentally test whether nocturnal wakefulness contributes to suicide-associated cognitive and affective processes and to identify underlying chronobiological mechanisms.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Denisse Armenta
- Phone Number: 5206261737
- Email: armentamd@arizona.edu
Study Contact Backup
- Name: Darilyn Rivera-Collazo, MS
- Phone Number: 5206264746
- Email: darilyn@arizona.edu
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85724
- Recruiting
- University of Arizona - Center for Sleep, Circadian, and Neuroscience Research
-
Contact:
- Darilyn Rivera-Collazo, MS
- Phone Number: 520-626-4746
- Email: darilyn@arizona.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Age 18-55 years
- History of suicidal ideation within the past 6 months
- Habitual bedtime between 9:00 PM and 1:00 AM
- Habitual wake time between 6:00 AM and 9:00 AM
- Ability to provide informed consent
Exclusion Criteria:
- Current suicidal intent requiring immediate clinical intervention
- Diagnosis of a primary sleep disorder (e.g., untreated obstructive sleep apnea, narcolepsy)
- Bipolar disorder or psychotic disorder
- Substance use disorder within the past 3 months
- Use of medications that significantly affect sleep or circadian rhythms
- Night shift work or transmeridian travel within the past month
- Medical or neurological condition that would interfere with participation
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Sleep Pressure Condition
Participants will remain awake until 2:00 AM to induce high homeostatic sleep pressure.
During the biological night (2:00-4:00 AM), participants will complete assessments of mood, suicidal ideation, impulsivity, and decision-making under conditions of sustained wakefulness.
|
Participants undergo an experimental manipulation of homeostatic sleep pressure involving controlled wakefulness or scheduled awakening during the biological night.
Mood, suicidal ideation, impulsivity, and decision-making are assessed during overnight laboratory sessions.
|
|
Experimental: Low Sleep Pressure Condition
Participants will be allowed to sleep and will be awakened at 2:00 AM to induce lower homeostatic sleep pressure.
During the biological night (2:00-4:00 AM), participants will complete assessments of mood, suicidal ideation, impulsivity, and decision-making following sleep and acute awakening.
|
Participants undergo an experimental manipulation of homeostatic sleep pressure involving controlled wakefulness or scheduled awakening during the biological night.
Mood, suicidal ideation, impulsivity, and decision-making are assessed during overnight laboratory sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feelings of Hopelessness
Time Frame: Visit 1(day 2, night 2), Visit 2 (day 2, night 2)
|
Total score on the BECK Hopelessness scale (BHS)
|
Visit 1(day 2, night 2), Visit 2 (day 2, night 2)
|
|
Impaired Executive Function
Time Frame: Visit 1(day 2, night 2), Visit 2 (day 2, night 2)
|
BART total score
|
Visit 1(day 2, night 2), Visit 2 (day 2, night 2)
|
|
Negative Mood
Time Frame: Visit 1(day 2, night 2), Visit 2 (day 2, night 2)
|
PANAS negative affect score
|
Visit 1(day 2, night 2), Visit 2 (day 2, night 2)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael A Grandner, PhD, University of Arizona
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Behavioral Symptoms
- Self-Injurious Behavior
- Dyssomnias
- Suicide
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Suicidal Ideation
- Sleep Wake Disorders
- Sleep Deprivation
- Impulsive Behavior
- Chronobiology Disorders
Other Study ID Numbers
- R01MH135978 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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