Back to resultsNeuro-affective Response to Light in Depressed Adolescents and Young Adults
Primary Purpose
Depression in Adolescence, Depression in Adults
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blue Light
Red Light
Sponsored by
About this trial
This is an interventional other trial for Depression in Adolescence
Eligibility Criteria
Inclusion Criteria: DSM-5 major depressive episode (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 Use of psychotropic medication other than stable Selective Serotonin Reuptake Inhibitor (SSRI) medication (> 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
Sites / Locations
- Western Psychiatric HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Blue then Red Light
Red Light then Blue Light
Arm Description
Blue light (480 nm) then Red light (640 nm)
Red light (640 nm) then Blue light (480 nm)
Outcomes
Primary Outcome Measures
Amygdala cerebral blood flow during Blue vs Red light exposure
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.
Ventral Striatum cerebral blood flow during Blue vs Red light exposure
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.
Amygdala activity (loss>neutral) during Blue vs Red light exposure
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.
Ventral Striatum activity (punish>neutral) during Blue vs Red light exposure
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.
Secondary Outcome Measures
Medial prefrontal cortex cerebral blood flow during Blue vs Red light exposure
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.
Insula cerebral blood flow during Blue vs Red light exposure
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.
Ventromedial prefrontal cortex cerebral blood flow during Blue vs Red light exposure
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.
Amygdala-whole brain functional connectivity (loss>neutral) during Blue vs Red light exposure
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
Ventromedial prefrontal cortex activity (loss>neutral) during Blue vs Red light exposure
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.
Insula activity (loss>neutral) during Blue vs Red light exposure
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.
Medial prefrontal cortex activity (win>neutral) during Blue vs Red light exposure
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.
Ventral striatum-whole brain functional connectivity (win>neutral) during Blue vs Red light exposure
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.
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
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.
Full Information
NCT ID
NCT05712772
First Posted
January 25, 2023
Last Updated
September 6, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05712772
Brief Title
Neuro-affective Response to Light in Depressed Adolescents and Young Adults
Official Title
Neuro-affective Response to Light in Depressed Adolescents and Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Adolescence, Depression in Adults
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All participants will receive blue and red light exposures; order of red vs. blue light will be counterbalanced across participants.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blue then Red Light
Arm Type
Experimental
Arm Description
Blue light (480 nm) then Red light (640 nm)
Arm Title
Red Light then Blue Light
Arm Type
Experimental
Arm Description
Red light (640 nm) then Blue light (480 nm)
Intervention Type
Other
Intervention Name(s)
Blue Light
Intervention Description
Blue light exposure
Intervention Type
Other
Intervention Name(s)
Red Light
Intervention Description
Red light exposure
Primary Outcome Measure Information:
Title
Amygdala cerebral blood flow during Blue vs Red light exposure
Description
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.
Time Frame
Collected during the blue and red light exposures during the MRI scan at the lab visit
Title
Ventral Striatum cerebral blood flow during Blue vs Red light exposure
Description
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.
Time Frame
Collected during the blue and red light exposures during the MRI scan at the lab visit
Title
Amygdala activity (loss>neutral) during Blue vs Red light exposure
Description
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.
Time Frame
Collected during the blue and red light exposures during the MRI scan at the lab visit
Title
Ventral Striatum activity (punish>neutral) during Blue vs Red light exposure
Description
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.
Time Frame
Collected during the blue and red light exposures during the MRI scan at the lab visit
Secondary Outcome Measure Information:
Title
Medial prefrontal cortex cerebral blood flow during Blue vs Red light exposure
Description
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.
Time Frame
Collected during the blue and red light exposures during the MRI scan at the lab visit
Title
Insula cerebral blood flow during Blue vs Red light exposure
Description
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.
Time Frame
Collected during the blue and red light exposures during the MRI scan at the lab visit
Title
Ventromedial prefrontal cortex cerebral blood flow during Blue vs Red light exposure
Description
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.
Time Frame
Collected during the blue and red light exposures during the MRI scan at the lab visit
Title
Amygdala-whole brain functional connectivity (loss>neutral) during Blue vs Red light exposure
Description
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
Time Frame
Collected during the blue and red light exposures during the MRI scan at the lab visit
Title
Ventromedial prefrontal cortex activity (loss>neutral) during Blue vs Red light exposure
Description
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.
Time Frame
Collected during the blue and red light exposures during the MRI scan at the lab visit
Title
Insula activity (loss>neutral) during Blue vs Red light exposure
Description
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.
Time Frame
Collected during the blue and red light exposures during the MRI scan at the lab visit
Title
Medial prefrontal cortex activity (win>neutral) during Blue vs Red light exposure
Description
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.
Time Frame
Collected during the blue and red light exposures during the MRI scan at the lab visit
Title
Ventral striatum-whole brain functional connectivity (win>neutral) during Blue vs Red light exposure
Description
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.
Time Frame
Collected during the blue and red light exposures during the MRI scan at the lab visit
Title
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
Description
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.
Time Frame
Collected during the blue and red light exposures during the MRI scan at the lab visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-5 major depressive episode
(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
Use of psychotropic medication other than stable Selective Serotonin Reuptake Inhibitor (SSRI) medication (> 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adriane M Soehner, PhD
Phone
4122466651
Email
soehneram2@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Allison Caswell, BS
Phone
4122466652
Email
caswella@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriane M Soehner, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Caswell
Phone
412-246-6652
Email
caswella@upmc.edu
First Name & Middle Initial & Last Name & Degree
Adriane M Soehner, PhD
First Name & Middle Initial & Last Name & Degree
Henry Chase, PhD
First Name & Middle Initial & Last Name & Degree
Kathryn Roecklein, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Raw data and data from descriptive/raw measures will be submitted on a semi-annual basis by July 15 and January 15 or the next business day. We also agree to submit to NDA the analyzed data yielded in our project (i.e., 12 months after accomplishment of each primary aim or objective, or immediately upon publication of the project's primary results, whichever occurs first). The PIs reserve the right to publish on the stated aims in a timely manner during the period of the award. Data will be available for addressing other research questions (i.e. which are not described in funded/pending grants) as soon as the data have been checked for accuracy (a period which will be no later than one year after the completion of each assessment). After the award has ended, the study investigators will continue to test the stated aims, but will also continue to solicit collaborations with outside researchers and to consider data requests in a timely manner.
IPD Sharing Access Criteria
Outside investigators must submit a 1) proposal of the study aims, hypotheses, variables/constructs, analytic approach, and estimated duration of the proposed research; 2) resume, qualifications, source of financial support, and conflict of interest statement; 3)sign a data-sharing agreement and confidentiality statement that stipulates using the data for the stated research purposes only, securing the data using appropriate computer technology, not manipulating the data in order to identify participants, acknowledging the grant that supported data collection and management in publications/presentations, and destroying or returning the data after analyses are complete; 4) obtain approval from their Institutional Review Board, and along with other staff members who have access to the data, submit certificates of human subjects protection training.
IPD Sharing URL
https://nda.nih.gov/
Learn more about this trial
Neuro-affective Response to Light in Depressed Adolescents and Young Adults
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