Depression in AdolescenceMoDANCT05691439
Mechanisms of Depression and Anhedonia in Adolescents: Linking Sleep to Reward- and Stress-Related Brain Function
A study testing Sleep extension and advance and Regular sleep duration and timing in people with Depression in Adolescence, run by University of Oregon at 1 site in United States.
Trial summary
This research will use biobehavioral approaches to generate understanding about the linkages between sleep duration and timing, stressful life events, and depressive symptoms in adolescents, with a long-term aim of developing effective preventative interventions. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Depression in Adolescence
- What is being tested?
- Sleep extension and advance and Regular sleep duration and timing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 31 Dec 2026
- Phase
- Interventional
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 14-18 years of age
- Currently in high school
- short and late sleep (weekday sleep duration ≤ 7 h and bedtime ≥ 22:30 (10:30 pm); n=100) or long and early sleep (weekday sleep duration > 7 hours and bedtime ≤ 22:30 (10:30 pm); n=50), indexed by the Munich Chronotype Questionnaire
- Lifetime stressful event frequency ≥ 2 on the Stress and Adversity Inventory (STRAIN) Screener
- Depressive symptom severity t-score greater than or equal to 45 on the Patient Reported Outcomes (PROMIS) Depression scale
- English language fluency
Who cannot join
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for current moderate to severe alcohol/substance use disorder (≥4 symptoms);
- Current clinician-provided diagnosis of narcolepsy or idiopathic hypersomnia;
- Lifetime diagnosis of bipolar or schizophrenia spectrum disorder;
- Certain medical conditions (e.g., serious neurological disorder, heart failure or serious heart trouble, history of head injury with unconsciousness > 5 minutes);
- Conditions that are contraindicated for magnetic resonance imaging (MRI; e.g., ferrous metal in the body);
- Positive screen for participant-reported eye disease, epilepsy, or photosensitizing medications that are contraindicated during the manipulation condition when bright light is administered (e.g., psychiatric neuroleptic drugs [e.g., phenothiazine], psoralen drugs, antiarrhythmic drugs [e.g., amiodarone], antimalarial and antirheumatic drugs, porphyrin drugs used in photodynamic treatment of skin diseases);
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- Use of melatonin if participant is not willing to discontinue use for the duration of the study.
- We will schedule around (i.e., delay appointments as needed) to avoid the timeframe of the following events:
- urgent suicide risk, defined by moderate/severe risk per Columbia Suicide Severity Rating Scale (CSSRS) and clinician determination that current risk requires immediate action;
- travel across two or more time zones within the month prior to the overnight study visits;
- beginning or ending a prescribed medication within 2 months of the observational study;
- prescribed medication dose changes within the timeframe calculated as 5x the drug's half-life [the time to reach pharmacokinetic steady-state] before the initiation of the observational or experimental studies;
- anticipated change in prescribed medications or medication dosing during the observational or experimental studies;
- current symptoms of airborne infectious illness prior to laboratory visits.
- Participants with positive breathalyzer screen (blood alcohol level > .02) will be rescheduled for an alternative overnight visit date.
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
University of Oregon
Eugene, Oregon, 97403
Melynda D Casement, 5413467051, casement@uoregon.edu
About this study
Official title: Mechanisms of Depression and Anhedonia in Adolescents: Linking Sleep Duration and Timing to Reward- and Stress-Related Brain Function
This research will use biobehavioral approaches to generate understanding about the linkages between sleep duration and timing, stressful life events, and depressive symptoms in adolescents, with a long-term aim of developing effective preventative interventions.
Read the detailed description
The last decade witnessed a steady growth from 8% to 14% in the prevalence of adolescents suffering from major depressive episode within the past year, and depression is expected to be the leading cause of global disability by 2030. The increase in depression incidence and disability is also related to increases in suicidality in adolescents, and the depressive symptom of anhedonia predicts suicidality above and beyond depression diagnosis. The high degree of morbidity and mortality associated with depression and anhedonia in adolescence makes this a key developmental period for research and intervention. Risk for depression and anhedonia is elevated in adolescents with insufficient sleep duration, late sleep timing, or elevated exposure to stressors. Alarmingly, only 30% of adolescents regularly obtain the recommended hours of sleep, and sleep timing is at its latest during mid- to late-adolescence. Adolescents also report high levels of stress related to work- and time-demands, and most will experience at least one major adverse life event before adulthood. Short/late sleep and stressors may also cause disruptions in reward- and stress-related brain function (e.g., medial prefrontal cortex response to monetary reward, autonomic and endocrine function during stressors), which are key biobehavioral mechanisms of depression and anhedonia. Short/late sleep habits are prime targets for depression intervention in adolescents; however, there is insufficient causal evidence that improving sleep opportunity and/or timing will alter the biobehavioral mechanisms of depression.
The overall objective of this R01 is to evaluate a biobehavioral model whereby sufficient sleep duration and/or early sleep timing can reduce depressive symptoms and anhedonia by promoting reward- and stress-related brain function in adolescents. The long-term goal of this research is to leverage sleep and circadian function to promote mental health. A series of studies by the PI and Co-Is indicate that short sleep, late sleep, and stressful life events independently predict reward- and stress-related brain function and depressive symptoms in adolescents. However, these studies do not evaluate the interactive effects of sleep/circadian function and stressful life events, or use experimental designs. More recent research by the PI and Co-Is uses sleep-circadian manipulation to target reward- and stress-related brain function and improve mental health in adolescents. Building from this research, this R01 will test the central hypothesis that extending and/or advancing sleep will alter reward- and stress-related brain function, and decrease depressive symptoms and anhedonia, in adolescents with short and late sleep. This proposal is consistent with the National Institute of Mental Health (NIMH) Strategic Objective to identify clinically meaningful biomarkers and behavioral indicators of mental health.
- Conditions
- Depression in Adolescence
- Being tested
- Sleep extension and advance, Regular sleep duration and timing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep extension and advanceBehavioural
Also called Lark routine
Participants in the sleep extension and advance condition will maintain a stable sleep schedule that extends sleep duration and advances bedtime by 90 min relative to weekday bedtime. This chronotherapeutic manipulation will include blocking phase-delaying light in the evening using goggles with orange lenses ("blue blockers") beginning 2 h prior to bedtime, and 30 min of 506 lux blue-green light exposure in the morning beginning at rise time using bright light goggles (ReTimer Pty Ltd., Australia). Schedule and chronotherapy adherence will be reinforced using motivational techniques (e.g., securing motivation, preplanning, problem-solving), requiring participants to text the study coordinator and complete morning assessments at rise time, and monetary incentives.
Regular sleep duration and timingBehavioural
Also called Owl routine
Participants in the regular sleep duration and timing condition will keep a stable sleep schedule that matches their typical weekday sleep opportunity and timing. Schedule adherence will be reinforced using motivational techniques (e.g., securing motivation, preplanning, problem-solving), requiring participants to text the study coordinator and complete morning assessments at rise time, and monetary incentives.
| Study group | Role | What they receive |
|---|---|---|
| Sleep extension and advance "Lark Routine" | Experimental | Participants go to bed 90 minutes earlier than their typical average bedtime to extend sleep duration and advance sleep timing Receives: Behavioral: Sleep extension and advance |
| Regular sleep duration and timing "Owl Routine" | Active comparator | Participants go to bed at their typical average bedtime Receives: Behavioral: Regular sleep duration and timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scale - Short Form (8-item)
The Patient-Reported Outcomes Measurement Information System (PROMIS) scale for Depression (8-item short form) will be administered at baseline, after each 2-week interval of intensive monitoring, and at follow-up, in reference to the past 7 days. The measure uses 5-point Likert scales, with scores ranging from 8 to 40 and higher scores indicating higher depression and lower scores indicating better outcome. Raw scores are converted to standardized T-scores using conversion tables published on the PROMIS website (nihpromis.org). T-scores of 50 represent the mean of the standardized sample.
Measured: 2 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Positive Affect Scale - Short Form (8-item)
The Patient-Reported Outcomes Measurement Information System (PROMIS)scale for Positive Affect (8-item short form) will be administered at baseline, after each 2-week interval of intensive monitoring, and at follow-up, in reference to the past 7 days. The measure uses 5-point Likert scales, with scores ranging from 8 to 40 and higher scores indicating higher positive affect and better outcome. Raw scores are converted to standardized T-scores using conversion tables published on the PROMIS website (nihpromis.org). T-scores of 50 represent the mean of the standardized sample.
Measured: 2 months
Dimensional Anhedonia Rating Scale (DARS)
The Dimensional Anhedonia Rating Scale (DARS) will be used to assess state anhedonia related to 4 domains: hobbies, food/drink, social activities, and sensory experience. The 17-item measure assesses hedonic experiences "right now" using 4-point Likert scales. The DARS has high reliability and good convergent and divergent validity. The DARS scores range from 0 to 68, with higher scores indicating lower anhedonia and better outcome.
Measured: 2 months
Reward-related brain function
Functional magnetic resonance imaging (fMRI) during the Monetary Incentive Delay (MID) task will be used to measure blood oxygen level dependent (BOLD) regional response and functional connectivity related to anticipation and receipt of monetary rewards. This task reliably elicits activation in neural reward circuitry and is sensitive to depression and sleep/circadian factors.
Measured: 2 weeks
Stress-related brain function
Stress-related brain function will be indexed using autonomic and neuroendocrine measures taken before and during the Trier Social Stress Task (TSST). The TSST is a lab-based social-evaluative threat task that reliably elicits subjective stress and increases in the stress-hormone cortisol.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start27 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in AdolescenceStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Research Institute, University of Pittsburgh, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Melynda Casement, University of Oregon
- Investigators
- Melynda D Casement, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691439
- Sponsor's protocol ID
- 217730
- Other IDs
- R01MH126109
- Acronym
- MoDA
- Status last verified
- Nov 2025
- First submitted
- 7 Sep 2022
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared through publication of findings in scientific publications, and through investigator responses to direct data requests from members of the scientific community. We will make available to the research community any resource that is presented in a publication that is published or accepted for publication. We agree to release and share data in a timely manner. Should any intellectual property arise that may be patentable, the University of Oregon will ensure that the related technology (materials and final research data) remains widely available in timely fashion to the research community in compliance with policies and regulations governing research awards from the NIH. Participant data shared outside of the University of Oregon will be free of identifying information that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Depression and Anhedonia in Adolescents: Linking Sleep Duration and Timing to Reward- and Stress-Related Brain Function
- ClinicalTrials.gov ID
- NCT05691439
- Acronym / sponsor ID
- MoDA / 217730
- Conditions
- Depression in Adolescence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- Oregon Research Institute, University of Pittsburgh, National Institute of Mental Health (NIMH)
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2023 (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.
This research will use biobehavioral approaches to generate understanding about the linkages between sleep duration and timing, stressful life events, and depressive symptoms in adolescents, with a long-term aim of developing effective preventative interventions.
Detailed description
The last decade witnessed a steady growth from 8% to 14% in the prevalence of adolescents suffering from major depressive episode within the past year, and depression is expected to be the leading cause of global disability by 2030. The increase in depression incidence and disability is also related to increases in suicidality in adolescents, and the depressive symptom of anhedonia predicts suicidality above and beyond depression diagnosis. The high degree of morbidity and mortality associated with depression and anhedonia in adolescence makes this a key developmental period for research and intervention. Risk for depression and anhedonia is elevated in adolescents with insufficient sleep duration, late sleep timing, or elevated exposure to stressors. Alarmingly, only 30% of adolescents regularly obtain the recommended hours of sleep, and sleep timing is at its latest during mid- to late-adolescence. Adolescents also report high levels of stress related to work- and time-demands, and most will experience at least one major adverse life event before adulthood. Short/late sleep and stressors may also cause disruptions in reward- and stress-related brain function (e.g., medial prefrontal cortex response to monetary reward, autonomic and endocrine function during stressors), which are key biobehavioral mechanisms of depression and anhedonia. Short/late sleep habits are prime targets for depression intervention in adolescents; however, there is insufficient causal evidence that improving sleep opportunity and/or timing will alter the biobehavioral mechanisms of depression.
The overall objective of this R01 is to evaluate a biobehavioral model whereby sufficient sleep duration and/or early sleep timing can reduce depressive symptoms and anhedonia by promoting reward- and stress-related brain function in adolescents. The long-term goal of this research is to leverage sleep and circadian function to promote mental health. A series of studies by the PI and Co-Is indicate that short sleep, late sleep, and stressful life events independently predict reward- and stress-related brain function and depressive symptoms in adolescents. However, these studies do not evaluate the interactive effects of sleep/circadian function and stressful life events, or use experimental designs. More recent research by the PI and Co-Is uses sleep-circadian manipulation to target reward- and stress-related brain function and improve mental health in adolescents. Building from this research, this R01 will test the central hypothesis that extending and/or advancing sleep will alter reward- and stress-related brain function, and decrease depressive symptoms and anhedonia, in adolescents with short and late sleep. This proposal is consistent with the National Institute of Mental Health (NIMH) Strategic Objective to identify clinically meaningful biomarkers and behavioral indicators of mental health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep extension and advance "Lark Routine" | Experimental | Behavioral: Sleep extension and advanceParticipants go to bed 90 minutes earlier than their typical average bedtime to extend sleep duration and advance sleep timing |
| Regular sleep duration and timing "Owl Routine" | Active comparator | Behavioral: Regular sleep duration and timingParticipants go to bed at their typical average bedtime |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 14-18 years of age
- Currently in high school
- short and late sleep (weekday sleep duration ≤ 7 h and bedtime ≥ 22:30 (10:30 pm); n=100) or long and early sleep (weekday sleep duration > 7 hours and bedtime ≤ 22:30 (10:30 pm); n=50), indexed by the Munich Chronotype Questionnaire
- Lifetime stressful event frequency ≥ 2 on the Stress and Adversity Inventory (STRAIN) Screener
- Depressive symptom severity t-score greater than or equal to 45 on the Patient Reported Outcomes (PROMIS) Depression scale
Key exclusion criteria (15 listed)
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for current moderate to severe alcohol/substance use disorder (≥4 symptoms);
- Current clinician-provided diagnosis of narcolepsy or idiopathic hypersomnia;
- Lifetime diagnosis of bipolar or schizophrenia spectrum disorder;
- Certain medical conditions (e.g., serious neurological disorder, heart failure or serious heart trouble, history of head injury with unconsciousness > 5 minutes);
- Conditions that are contraindicated for magnetic resonance imaging (MRI; e.g., ferrous metal in the body);
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 |
|---|---|---|
| Sleep extension and advanceAlso: Lark routineParticipants in the sleep extension and advance condition will maintain a stable sleep schedule that extends sleep duration and advances bedtime by 90 min relative to weekday bedtime. This chronotherapeutic manipulation will include blocking phase-delaying light in the evening using goggles with orange lenses ("blue blockers") beginning 2 h prior to bedtime, and 30 min of 506 lux blue-green light exposure in the morning beginning at rise time using bright light goggles (ReTimer Pty Ltd., Australia). Schedule and chronotherapy adherence will be reinforced using motivational techniques (e.g., securing motivation, preplanning, problem-solving), requiring participants to text the study coordinator and complete morning assessments at rise time, and monetary incentives. | Behavioural | Sleep extension and advance "Lark Routine" |
| Regular sleep duration and timingAlso: Owl routineParticipants in the regular sleep duration and timing condition will keep a stable sleep schedule that matches their typical weekday sleep opportunity and timing. Schedule adherence will be reinforced using motivational techniques (e.g., securing motivation, preplanning, problem-solving), requiring participants to text the study coordinator and complete morning assessments at rise time, and monetary incentives. | Behavioural | Regular sleep duration and timing "Owl Routine" |
Primary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scale - Short Form (8-item)
Time frame: 2 months
The Patient-Reported Outcomes Measurement Information System (PROMIS) scale for Depression (8-item short form) will be administered at baseline, after each 2-week interval of intensive monitoring, and at follow-up, in reference to the past 7 days. The measure uses 5-point Likert scales, with scores ranging from 8 to 40 and higher scores indicating higher depression and lower scores indicating better outcome. Raw scores are converted to standardized T-scores using conversion tables published on the PROMIS website (nihpromis.org). T-scores of 50 represent the mean of the standardized sample.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Positive Affect Scale - Short Form (8-item)
Time frame: 2 months
The Patient-Reported Outcomes Measurement Information System (PROMIS)scale for Positive Affect (8-item short form) will be administered at baseline, after each 2-week interval of intensive monitoring, and at follow-up, in reference to the past 7 days. The measure uses 5-point Likert scales, with scores ranging from 8 to 40 and higher scores indicating higher positive affect and better outcome. Raw scores are converted to standardized T-scores using conversion tables published on the PROMIS website (nihpromis.org). T-scores of 50 represent the mean of the standardized sample.
Dimensional Anhedonia Rating Scale (DARS)
Time frame: 2 months
The Dimensional Anhedonia Rating Scale (DARS) will be used to assess state anhedonia related to 4 domains: hobbies, food/drink, social activities, and sensory experience. The 17-item measure assesses hedonic experiences "right now" using 4-point Likert scales. The DARS has high reliability and good convergent and divergent validity. The DARS scores range from 0 to 68, with higher scores indicating lower anhedonia and better outcome.
Reward-related brain function
Time frame: 2 weeks
Functional magnetic resonance imaging (fMRI) during the Monetary Incentive Delay (MID) task will be used to measure blood oxygen level dependent (BOLD) regional response and functional connectivity related to anticipation and receipt of monetary rewards. This task reliably elicits activation in neural reward circuitry and is sensitive to depression and sleep/circadian factors.
Stress-related brain function
Time frame: 2 weeks
Stress-related brain function will be indexed using autonomic and neuroendocrine measures taken before and during the Trier Social Stress Task (TSST). The TSST is a lab-based social-evaluative threat task that reliably elicits subjective stress and increases in the stress-hormone cortisol.
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 17 Nov 2025.
- Individual participant dataSharing planned: Yes. Data will be shared through publication of findings in scientific publications, and through investigator responses to direct data requests from members of the scientific community. We will make available to the research community any resource that is presented in a publication that is published or accepted for publication. We agree to release and share data in a timely manner. Should any intellectual property arise that may be patentable, the University of Oregon will ensure that the related technology (materials and final research data) remains widely available in timely fashion to the research community in compliance with policies and regulations governing research awards from the NIH. Participant data shared outside of the University of Oregon will be free of identifying information that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.
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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.
Melynda D Casement, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep extension and advance and Regular sleep duration and timing in people with Depression in Adolescence, run by University of Oregon 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 6 inclusion and 15 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 17 Nov 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.
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 Amanda Johnson (541-346-4107, anj@uoregon.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scale - Short Form (8-item) (time frame: 2 months). The study lists 5 primary outcomes in all. 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 17 Nov 2025.