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

NCT05712772 | Recruiting

• 2 other identifiers: STUDY22040093R21MH127294
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Depression in Adolescence; Depression in Adults

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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

  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

  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 Outcomes (9)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Blue then Red Light

EXPERIMENTAL

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

Other: Blue Light; Other: Red Light

Red Light then Blue Light

EXPERIMENTAL

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

Other: Blue Light; Other: Red Light

Interventions

Blue Light OTHER

Blue light exposure

Blue then Red Light; Red Light then Blue Light

Red Light OTHER

Red light exposure

Blue then Red Light; Red Light then Blue Light

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Elevated Depressive Symptoms \[PHQ9≥5 And (Item 1≥1 or Item 2≥1)\]
• (If \<18yr) Parent or guardian can attend the baseline clinical interview

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Western Psychiatric Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Interventions

Blue Light; Red Light

Intervention Hierarchy (Ancestors)

Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Study Officials

• Adriane M Soehner, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriane M Soehner, PhD

CONTACT

4122466651; soehneram2@upmc.edu

Allison Caswell, BS

CONTACT

4122466652; caswella@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants will receive blue and red light exposures; order of red vs. blue light will be counterbalanced across participants.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: June 14, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (1)