- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05712772
Neuro-affective Response to Light in Depressed Adolescents and Young Adults
The goal of this neuroimaging pilot study is to understand developmental differences in the impact of therapeutic wavelength light (blue light) versus a non-therapeutic wavelength (red light) on emotional brain function in depression. The main questions this study aims to answer are:
- Does acute exposure to blue light (vs red light) stabilize emotional brain function in depressed individuals?
- Are stabilizing effects of blue light (vs red light) stronger for blue light in adolescents than young adults?
Participants will complete:
- A magnetic resonance imaging brain scan, in which we will examine the effect of blue versus red light on emotional brain function at rest and in response to rewards and losses.
- A pupillometry test of sensitivity to blue vs red light
- Clinical interviews and surveys
- Screening measures for drug and alcohol use, MRI safety, and current pregnancy [if relevant]
- Home sleep tracking with sleep diary and actigraphy for one week
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adriane M Soehner, PhD
- Phone Number: 4122466651
- Email: soehneram2@upmc.edu
Study Contact Backup
- Name: Allison Caswell, BS
- Phone Number: 4122466652
- Email: caswella@upmc.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- Western Psychiatric Hospital
-
Contact:
- Allison Caswell
- Phone Number: 412-246-6652
- Email: caswella@upmc.edu
-
Principal Investigator:
- Adriane M Soehner, PhD
-
Sub-Investigator:
- Henry Chase, PhD
-
Sub-Investigator:
- Kathryn Roecklein, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Elevated Depressive Symptoms [PHQ9≥5 And (Item 1≥1 or Item 2≥1)]
- (If <18yr) Parent or guardian can attend the baseline clinical interview
Exclusion Criteria:
- Unable to read and write in English
- Intellectual disability.
- Left or mixed handedness
- Changes to psychotropic medication type or dosage in the past 2 months
- Lifetime bipolar disorder or schizophrenia, or substance/alcohol disorder in the past 3 months.
- Factors influencing light and color sensitivity (i.e., color-blindness, serious ophthalmological conditions, photo-sensitizing medication).
- Factors influencing the ability to maintain a stable sleep schedule (i.e., shift work, severe sleep disorders, extremely late or early sleep schedule).
- Severe medical illness, neurological disorders, or history of head trauma.
- Current pregnancy or nursing
- MRI contraindication (e.g., metals in the body, recent tattoo, claustrophobia)
- Positive alcohol or substance use screen at MRI visit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blue then Red Light
Blue light (480 nm) then Red light (640 nm)
|
Blue light exposure
Red light exposure
|
|
Experimental: Red Light then Blue Light
Red light (640 nm) then Blue light (480 nm)
|
Blue light exposure
Red light exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amygdala cerebral blood flow during Blue vs Red light exposure
Time Frame: Collected during the blue and red light exposures during the MRI scan at the lab visit
|
Cerebral blood flow will be assessed using pseudo-continuous arterial spin labeling collected during blue and red light exposures.
Regional cerebral blood flow in the amygdala region of interest will be examined.
|
Collected during the blue and red light exposures during the MRI scan at the lab visit
|
|
Ventral Striatum cerebral blood flow during Blue vs Red light exposure
Time Frame: Collected during the blue and red light exposures during the MRI scan at the lab visit
|
Cerebral blood flow will be assessed using pseudo-continuous arterial spin labeling collected during blue and red light exposures.
Regional cerebral blood flow in the ventral striatum region of interest will be examined.
|
Collected during the blue and red light exposures during the MRI scan at the lab visit
|
|
Amygdala activity (loss>neutral) during Blue vs Red light exposure
Time Frame: Collected during the blue and red light exposures during the MRI scan at the lab visit
|
This outcome will be measured during the an auditory probabilistic reward task, which is a computerized fMRI behavioral task.
Activation is defined by blood oxygen dependent signal within an amygdala region of interest on loss versus neutral (no win/no loss) trials.
|
Collected during the blue and red light exposures during the MRI scan at the lab visit
|
|
Ventral Striatum activity (punish>neutral) during Blue vs Red light exposure
Time Frame: Collected during the blue and red light exposures during the MRI scan at the lab visit
|
This outcome will be measured during the an auditory probabilistic reward task, which is a computerized fMRI behavioral task.
Activation is defined by blood oxygen dependent signal within a ventral striatum region of interest on win versus neutral (no win/no loss) trials.
|
Collected during the blue and red light exposures during the MRI scan at the lab visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medial prefrontal cortex cerebral blood flow during Blue vs Red light exposure
Time Frame: Collected during the blue and red light exposures during the MRI scan at the lab visit
|
Cerebral blood flow will be assessed using pseudo-continuous arterial spin labeling collected during blue and red light exposures.
Regional cerebral blood flow in the medial prefrontal region of interest will be examined.
|
Collected during the blue and red light exposures during the MRI scan at the lab visit
|
|
Insula cerebral blood flow during Blue vs Red light exposure
Time Frame: Collected during the blue and red light exposures during the MRI scan at the lab visit
|
Cerebral blood flow will be assessed using pseudo-continuous arterial spin labeling collected during blue and red light exposures.
Regional cerebral blood flow in the insula regions of interest will be examined.
|
Collected during the blue and red light exposures during the MRI scan at the lab visit
|
|
Ventromedial prefrontal cortex cerebral blood flow during Blue vs Red light exposure
Time Frame: Collected during the blue and red light exposures during the MRI scan at the lab visit
|
Cerebral blood flow will be assessed using pseudo-continuous arterial spin labeling collected during blue and red light exposures.
Regional cerebral blood flow in the ventromedial prefrontal cortex regions of interest will be examined.
|
Collected during the blue and red light exposures during the MRI scan at the lab visit
|
|
Amygdala-whole brain functional connectivity (loss>neutral) during Blue vs Red light exposure
Time Frame: Collected during the blue and red light exposures during the MRI scan at the lab visit
|
This outcome will be measured during the an auditory probabilistic reward task, which is a computerized fMRI behavioral task.
Functional connectivity is defined as a psychophysiological interaction between the seed region (amygdala) and the whole brain on loss versus neutral (no win/no loss) trials
|
Collected during the blue and red light exposures during the MRI scan at the lab visit
|
|
Ventromedial prefrontal cortex activity (loss>neutral) during Blue vs Red light exposure
Time Frame: Collected during the blue and red light exposures during the MRI scan at the lab visit
|
This outcome will be measured during the an auditory probabilistic reward task, which is a computerized fMRI behavioral task.
Activation is defined by blood oxygen dependent signal within the ventromedial prefrontal cortex region of interest on loss versus neutral (no win/no loss) trials.
|
Collected during the blue and red light exposures during the MRI scan at the lab visit
|
|
Insula activity (loss>neutral) during Blue vs Red light exposure
Time Frame: Collected during the blue and red light exposures during the MRI scan at the lab visit
|
This outcome will be measured during the an auditory probabilistic reward task, which is a computerized fMRI behavioral task.
Activation is defined by blood oxygen dependent signal within the insula region of interest on loss versus neutral (no win/no loss) trials.
|
Collected during the blue and red light exposures during the MRI scan at the lab visit
|
|
Medial prefrontal cortex activity (win>neutral) during Blue vs Red light exposure
Time Frame: Collected during the blue and red light exposures during the MRI scan at the lab visit
|
This outcome will be measured during the an auditory probabilistic reward task, which is a computerized fMRI behavioral task.
Activation is defined by blood oxygen dependent signal within the medial prefrontal region of interest on win versus neutral (no win/no loss) trials.
|
Collected during the blue and red light exposures during the MRI scan at the lab visit
|
|
Ventral striatum-whole brain functional connectivity (win>neutral) during Blue vs Red light exposure
Time Frame: Collected during the blue and red light exposures during the MRI scan at the lab visit
|
This outcome will be measured during the an auditory probabilistic reward task, which is a computerized fMRI behavioral task.
Functional connectivity is defined as a psychophysiological interaction between the seed region (ventral striatum) and the whole brain.
|
Collected during the blue and red light exposures during the MRI scan at the lab visit
|
|
Ventromedial prefrontal cortex activity, insula, and medial prefrontal activity, and amygdala- and ventral striatum whole brain functional connectivity (response bias; B') during Blue vs Red light exposure
Time Frame: Collected during the blue and red light exposures during the MRI scan at the lab visit
|
This outcome will be measured during the an auditory probabilistic reward task, which is a computerized fMRI behavioral task.
Activation is defined by blood oxygen dependent signal within the above regions of interest using a response bias metric (B').
Functional connectivity is defined as a psychophysiological interaction between the seed regions (amygdala, ventral striatums) and the whole brain.
|
Collected during the blue and red light exposures during the MRI scan at the lab visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Adriane M Soehner, PhD, University of Pittsburgh
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY22040093
- R21MH127294 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The investigators will complete and submit a National Data Archive (NDA) Data Sharing Agreement within 6 months of the Notice of Award Issue date. Study staff will upload data dictionary to the NDA website, and will review the NDA data definition for the measures collected and define the project's data definition harmonized to that standard. For measures not yet defined, project staff will work with the NDA staff to define the measure following NDA best practices. Informed consent will be collected from study participants that allows for broad sharing of participants' de-identified data. Study staff will use participants' personally identifiable information to generate NDA Global Unique Identifier (GUID) numbers for study participants.
All data will be identified by GUID numbers only prior to submission to the NDA database. Data transfer procedures will be in accordance with all Institutional Review Board guidelines and federal regulations including HIPAA.
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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