Depression in AdolescenceNCT05712772
Neuro-affective Response to Light in Depressed Adolescents and Young Adults
A study testing Blue Light and Red Light in people with Depression in Adolescence and Depression in Adults, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Depression in Adolescence, Depression in Adults
- What is being tested?
- Blue Light and Red Light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2023to 14 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Elevated Depressive Symptoms [PHQ9≥5 And (Item 1≥1 or Item 2≥1)]
- (If <18yr) Parent or guardian can attend the baseline clinical interview
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Hospital
Pittsburgh, Pennsylvania, 15213
About this study
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?
Read more
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
- Being tested
- Blue Light, Red Light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue LightOther
Blue light exposure
Red LightOther
Red light exposure
| Study group | Role | What they receive |
|---|---|---|
| Blue then Red Light | Experimental | Blue light (480 nm) then Red light (640 nm) Receives: Other: Blue Light; Other: Red Light |
| Red Light then Blue Light | Experimental | Red light (640 nm) then Blue light (480 nm) Receives: Other: Blue Light; Other: Red Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Collected during the blue and red light exposures during the MRI scan at the lab visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start14 Jun 2023
- Primary completion14 Sep 2026 (estimated)
- Study completion14 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in AdolescenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Adriane Soehner, University of Pittsburgh
- Investigators
- Adriane M Soehner, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712772
- Sponsor's protocol ID
- STUDY22040093
- Other IDs
- R21MH127294
- Status last verified
- Aug 2026
- First submitted
- 25 Jan 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.