Light Therapy for Depression in Adolescent Outpatients
NCT05823090 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2023-04-25
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. characterize and define facilitators/barriers to treatment with BLT in adolescents);
2. evaluate the acceptability and feasibility of outpatient BLT in a dose titration protocol;
3. establish an effective, safe and tolerable light dose.
Conditions
- Depression
- Adolescent - Emotional Problem
Interventions
- DEVICE
-
light box (Carex DayLight Classic Model)
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.
Sponsors & Collaborators
-
Ann & Robert H Lurie Children's Hospital of Chicago
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-12-21
- Primary Completion
- 2022-11-08
- Completion
- 2022-11-08
- FDA Device
- Yes
Countries
- United States
Study Locations
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