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Recruiting NCT05712772

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

No phase Interventional Depression in Adolescence Depression in Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blue Light, Red Light.
Who it may be relevant to
Registry conditions: Depression in Adolescence, Depression in Adults. Basic parameters: 12 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Other Blue Light
    Blue light exposure
  • Other Red Light
    Red light exposure

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
Secondary outcome measures (9)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Western Psychiatric Hospital — Pittsburgh

Identifiers

NCT: NCT05712772 · STUDY22040093 · R21MH127294

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗