Neuro-affective Response to Light in Depressed Adolescents and Young Adults

Sponsor
University of Pittsburgh (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05712772
Collaborator
National Institute of Mental Health (NIMH) (NIH)
80
1
2
16.6
4.8

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Blue Light
  • Other: Red Light
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
All participants will receive blue and red light exposures; order of red vs. blue light will be counterbalanced across participants.All participants will receive blue and red light exposures; order of red vs. blue light will be counterbalanced across participants.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Neuro-affective Response to Light in Depressed Adolescents and Young Adults
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Blue then Red Light

Blue light (480 nm) then Red light (640 nm)

Other: Blue Light
Blue light exposure

Other: Red Light
Red light exposure

Experimental: Red Light then Blue Light

Red light (640 nm) then Blue light (480 nm)

Other: Blue Light
Blue light exposure

Other: Red Light
Red light exposure

Outcome Measures

Primary Outcome Measures

  1. Amygdala cerebral blood flow during Blue vs Red light exposure [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.

  2. Ventral Striatum cerebral blood flow during Blue vs Red light exposure [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.

  3. Amygdala activity (loss>neutral) during Blue vs Red light exposure [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.

  4. Ventral Striatum activity (punish>neutral) during Blue vs Red light exposure [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.

Secondary Outcome Measures

  1. Medial prefrontal cortex cerebral blood flow during Blue vs Red light exposure [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.

  2. Insula cerebral blood flow during Blue vs Red light exposure [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.

  3. Ventromedial prefrontal cortex cerebral blood flow during Blue vs Red light exposure [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.

  4. Amygdala-whole brain functional connectivity (loss>neutral) during Blue vs Red light exposure [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

  5. Ventromedial prefrontal cortex activity (loss>neutral) during Blue vs Red light exposure [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.

  6. Insula activity (loss>neutral) during Blue vs Red light exposure [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.

  7. Medial prefrontal cortex activity (win>neutral) during Blue vs Red light exposure [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.

  8. Ventral striatum-whole brain functional connectivity (win>neutral) during Blue vs Red light exposure [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.

  9. 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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Western Psychiatric Hospital Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • University of Pittsburgh
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Adriane M Soehner, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adriane Soehner, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT05712772
Other Study ID Numbers:
  • STUDY22040093
  • R21MH127294
First Posted:
Feb 3, 2023
Last Update Posted:
Feb 3, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2023