Light Therapy for Depression in Adolescent Outpatients

NCT05823090 | Completed Phase 4 FDA Device

• 1 other identifier: 2021-4706
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this placebo lead-in clinical trial was to test bright light therapy (BLT) in adolescents with depression. The main question\[s\] it aimed to answer were:

1. 1.characterize and define facilitators/barriers to treatment with BLT in adolescents);
2. 2.evaluate the acceptability and feasibility of outpatient BLT in a dose titration protocol;
3. 3.establish an effective, safe and tolerable light dose.

Conditions

Depression; Adolescent - Emotional Problem

Keywords

light therapy

Outcome Measures

Primary Outcomes (9)

• Adherence to BLT in adolescent outpatients with depression

  Adherence to prescribed daily light box use measured by days used as a percentage of days prescribed.

  8 week study period

• Change in depression severity with dim red light (BLT placebo)

  Depression severity measured by child- and parent-report Short Mood and Feelings Questionnaire (score ranges from 0-26, with higher scores indicating worse outcome).

  Baseline to study week 2

• Change in depression severity with BLT

  Depression severity measured by child- and parent-report Short Mood and Feelings Questionnaire (score ranges from 0-26, with higher score indicating worse outcome).

  Study week 2 to study week 8

• Treatment emergent mania with dim red light (BLT placebo) in adolescent outpatients with depression

  Adverse event occurring during placebo phase as monitored by the parent-reported Child Mania Rating Scale (score range 0-30, with higher scores indicating worse outcomes).

  Baseline to study week 2

• Treatment emergent mania with BLT in adolescent outpatients with depression

  Adverse event occurring during BLT as monitored by the parent-reported Child Mania Rating Scale (score range 0-30, with higher scores indicating worse outcomes).

  Study week 2 to study week 8

• Treatment emergent suicidality with dim red light (BLT placebo) in adolescent outpatients with depression

  Adverse event occurring during placebo phase as monitored by the patient-reported Columbia Suicide Severity Rating Scale (3 questions; any "yes" answer indicates need for further clinical assessment).

  Baseline to study week 2

• Treatment emergent suicidality with BLT in adolescent outpatients with depression

  Adverse event occurring during BLT as monitored by the patient-reported Columbia Suicide Severity Rating Scale (3 questions; any "yes" answer indicates need for further clinical assessment).

  Study week 2 to study week 8

• Treatment emergent adverse events with dim red light (BLT placebo) in adolescent outpatients with depression

  Adverse event occurring during placebo phase as monitored by the and patient-reported Systematic Assessment for Treatment Emergent Effects (SAFTEE, modified, 26 items; range for any item 1-5 with 5 indicating worse outcome).

  Baseline to study week 2

• Treatment emergent adverse events with BLT in adolescent outpatients with depression

  Adverse event occurring during BLT as monitored by the and patient-reported Systematic Assessment for Treatment Emergent Effects (SAFTEE, modified, 26 items; range for any item 1-5 with 5 indicating worse outcome).

  Study week 2 to study week 8

Secondary Outcomes (2)

• Change in anxiety with BLT

  Baseline to study week 8

• Sleep efficiency and sleep onset latency with changing dose of BLT

  Continuously through the 8-week study period

Study Arms (1)

Bright light therapy

EXPERIMENTAL

Eligible participants were provided a light box and an actigraphy wrist-watch and given instructions on the use of each. The light therapy dosing protocol was planned as follows: Weeks 0-2, 50 lux dim red light (DRL) x 15 30 minutes/day; weeks 3-4, 10,000 lux x 15 minutes/day; weeks 5-6, 10,000 lux x 30 minutes/day; weeks 6-8, 10,000 lux x 45 minutes/day. At week 2, the study coordinator dispensed the 10,000 lux BLT unit (and picked up the DRL box) and the actigraphy watch. Participants and their parent/guardian met with 2 study clinicians at the end of each 2-week period. One study clinician, who was blinded to the participant's light box use, conducted a brief interview regarding mood, safety and functioning and side effects. The other study clinician subsequently met with the participant to review safety, side effects and response and made recommendations on duration and timing of light box use based on level of improvement and any barriers to use.

Device: light box (Carex DayLight Classic Model)

Interventions

light box (Carex DayLight Classic Model) DEVICE

The active light box is a white fluorescent 4000 Kelvin unit that emits 10,000 lux and measures 33cm x 40cm. The placebo box emits 50 lux dim red light and appears identical to the active unit. Subjects were instructed to position themselves 30-36 cm from the box with their faces fully exposed to the light. The actigraphy device is a Phillips Spectrum Plus Actigraphy watch which collects activity level and sleep information along with multiple light measurements and wearer adherence.

Bright light therapy

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants with depression and elevated scores on youth screening measures, Patient Health Questionnaire-9 (PHQ-9 (≥ 9) or PHQ-2 (≥ 3).
• English-speaking primary caregiver legally able to provide consent and who could contribute weekly mood ratings.

You may not qualify if:

• Current or past diagnoses of bipolar disorder, moderate to severe autism, schizophrenia, or schizoaffective disorder, or intellectual disability; a major medical illness or ocular condition (e.g. glaucoma, retinal disease, macular degeneration) that would interfere with participation in the study; significant and imminent risk to self or to others; concurrent
• Recent (\<4 months) medication or new (\< 3 months) psychotherapy treatment for depression
• Current use of melatonin, beta-blockers, chloroquine, or regular non-steroidal anti-inflammatory agents, or St. John's Wort.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Rachel Ballard

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

• Oren DA, Brainard GC, Johnston SH, Joseph-Vanderpool JR, Sorek E, Rosenthal NE. Treatment of seasonal affective disorder with green light and red light. Am J Psychiatry. 1991 Apr;148(4):509-11. doi: 10.1176/ajp.148.4.509.

  PMID: 2006698 BACKGROUND

• Sit DK, McGowan J, Wiltrout C, Diler RS, Dills JJ, Luther J, Yang A, Ciolino JD, Seltman H, Wisniewski SR, Terman M, Wisner KL. Adjunctive Bright Light Therapy for Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2018 Feb 1;175(2):131-139. doi: 10.1176/appi.ajp.2017.16101200. Epub 2017 Oct 3.

  PMID: 28969438 BACKGROUND

• Wirz-Justice A, Bader A, Frisch U, Stieglitz RD, Alder J, Bitzer J, Hosli I, Jazbec S, Benedetti F, Terman M, Wisner KL, Riecher-Rossler A. A randomized, double-blind, placebo-controlled study of light therapy for antepartum depression. J Clin Psychiatry. 2011 Jul;72(7):986-93. doi: 10.4088/JCP.10m06188blu. Epub 2011 Apr 5.

  PMID: 21535997 BACKGROUND

• Garbazza C, Cirignotta F, D'Agostino A, Cicolin A, Hackethal S, Wirz-Justice A, Cajochen C, Manconi M; "Life-ON" study group. Sustained remission from perinatal depression after bright light therapy: A pilot randomised, placebo-controlled trial. Acta Psychiatr Scand. 2022 Oct;146(4):350-356. doi: 10.1111/acps.13482. Epub 2022 Aug 3.

  PMID: 35876837 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Participants were blinded as to the type of light they received from the BLT device. Participants were assessed by both a blinded and non-blinded investigator. The blinded investigator assigned the Clinical Global Impressions Severity and Improvement Scales. The non-blinded investigator made clinical decisions regarding the BLT dose.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: placebo lead-in open trial

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 21, 2023
• Study Start: December 21, 2021
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)