Clinical trial NCT05712772: 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
Overall status: RECRUITING
Phase: NA
Conditions: Depression in Adolescence
Depression in Adults
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-02-03
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will receive blue and red light exposures; order of red vs. blue light will be counterbalanced across participants.
Primary purpose: OTHER

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


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

Primary outcomes:
measure: Amygdala cerebral blood flow during Blue vs Red light exposure
timeFrame: Collected during the blue and red light exposures during the MRI scan at the lab visit
measure: Ventral Striatum cerebral blood flow during Blue vs Red light exposure
timeFrame: Collected during the blue and red light exposures during the MRI scan at the lab visit
measure: Amygdala activity (loss>neutral) during Blue vs Red light exposure
timeFrame: Collected during the blue and red light exposures during the MRI scan at the lab visit
measure: Ventral Striatum activity (punish>neutral) during Blue vs Red light exposure
timeFrame: Collected during the blue and red light exposures during the MRI scan at the lab visit
Secondary outcomes:
measure: Medial prefrontal cortex cerebral blood flow during Blue vs Red light exposure
timeFrame: Collected during the blue and red light exposures during the MRI scan at the lab visit
measure: Insula cerebral blood flow during Blue vs Red light exposure
timeFrame: Collected during the blue and red light exposures during the MRI scan at the lab visit
measure: Ventromedial prefrontal cortex cerebral blood flow during Blue vs Red light exposure
timeFrame: Collected during the blue and red light exposures during the MRI scan at the lab visit
measure: Amygdala-whole brain functional connectivity (loss>neutral) during Blue vs Red light exposure
timeFrame: Collected during the blue and red light exposures during the MRI scan at the lab visit
measure: Ventromedial prefrontal cortex activity (loss>neutral) during Blue vs Red light exposure
timeFrame: Collected during the blue and red light exposures during the MRI scan at the lab visit
measure: Insula activity (loss>neutral) during Blue vs Red light exposure
timeFrame: Collected during the blue and red light exposures during the MRI scan at the lab visit
measure: Medial prefrontal cortex activity (win>neutral) during Blue vs Red light exposure
timeFrame: Collected during the blue and red light exposures during the MRI scan at the lab visit
measure: Ventral striatum-whole brain functional connectivity (win>neutral) during Blue vs Red light exposure
timeFrame: Collected during the blue and red light exposures during the MRI scan at the lab visit
measure: 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
timeFrame: Collected during the blue and red light exposures during the MRI scan at the lab visit
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Adriane M Soehner, PhD
role: PRINCIPAL_INVESTIGATOR
References: