Clinical Efficacy, Safety, and Applicability of Home-based Bright Light Therapy in Outpatient Adolescents With Major Depressive Disorder

Clinical Efficacy, Safety, and Applicability of Home-based Bright Light Therapy in Outpatient Adolescents With Major Depressive Disorder in China: a Randomised Controlled Trial

Major Depressive Disorder (MDD) is a chronic disease characterized by a high prevalence, low cure rate, and significant disability. Globally, depression is recognized as the leading cause of illness and disability among children and adolescents. Bright light therapy (BLT) has been established as an effective treatment for seasonal affective disorder and has demonstrated considerable efficacy in adult patients with MDD. However, its application in adolescent patients with MDD remains largely unexplored. The aim of this clinical trial is to evaluate the clinical efficacy, onset time, safety, and applicability of BLT in adolescents with MDD and to explore the potential neural mechanisms by which BLT enhances emotional and cognitive function in this population. This is a multicenter, randomized, controlled, double-blind study. It will involve adolescents aged 13 to 17 who are either untreated or have been stable on medication for at least one week. Adolescents with MDD will be randomly assigned to one of three groups: a high-intensity bright white light intervention group, a medium-intensity bright white light intervention group, and a placebo control group receiving dim red light. Each group will undergo four weeks of light exposure, six days per week, for 40 minutes daily between 6:30 and 10:00 AM. During the light exposure period, follow-up assessments will be conducted every weekend, and participants will be followed for two weeks after the completion of light exposure.The primary outcome will be the change in total scores on the 17-item Hamilton Rating Scale for Depression (HAMD-17) from baseline to week 4. Secondary outcomes will include response and remission rates, time to onset, maintenance of efficacy, self-reported depressive symptoms, sleep quality, cognitive function, anxiety, irritability, suicidal ideation, non-suicidal self-injury, self-efficacy, and the overall safety profile of BLT.

Additionally, the study will include healthy adolescent controls and collect functional Near-Infrared Spectroscopy (fNIRS) from both the adolescent participants with major depressive disorder and the healthy controls at baseline. The fNIRS and MRI data will also be collected from the adolescent participants with MDD at the end of the intervention, in order to investigate the potential neural mechanisms by which light therapy alleviates depressive symptoms in adolescents.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Device: Bright light therapy（High light intensity）; Device: Bright light therapy（Low light intensity）; Device: Dim red light placebo-controlled intervention

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaozhen Lv; Phone Number: +8601062723705; Email: lxz120300@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 10000
      • Recruiting
      • Beijing HuiLongGuan Hospital
      • Contact: Ning Wang; Phone Number: +8615801677801; Email: frningwang@sina.com
    • Beijing, Beijing Municipality, China, 10000
      • Recruiting
      • Peking University Sixth Hospital
      • Contact: Xiaozhen Lv; Phone Number: 13911534301; Email: lvxiaozhen@bjmu.edu.cn
  • Shanxi
    • Yanan, Shanxi, China
      • Recruiting
      • Yan'an Third People's Hospital
      • Contact: Jun Yuan; Phone Number: +8618992159555; Email: 337559650@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

The inclusion and exclusion criteria for MDD patients：

1. inclusion criteria

   • Meeting DSM-IV diagnostic criteria for a major depressive episode (first-episode or recurrent) , confirmed by two experienced, independent psychiatrists using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid);
   • Aged 13-17 years ;
   • Medication-naïve or on a stable pharmacological regimen for ≥1 week prior to enrollment;
   • Baseline Hamilton Depression Rating Scale-17 (HAMD-17) score ≥14;
   • Minimum of 5 years of formal education, with the ability to complete clinical assessments and comprehend study-related information;
   • Voluntary participation with written informed consent provided by both participants and their legal guardians.

2. exclusion criteria

   • Current or past diagnosis of psychiatric disorders other than anxiety or sleep disorders;
   • History of substance abuse or dependence history (including alcohol, nicotine, or illicit drugs);
   • Baseline Young Mania Rating Scale (YMRS) total score ≥6;
   • Received or planned to initiate non-pharmacological systemic interventions within 6 months prior to enrollment or within 1 month after enrollment, including but not limited to: structured psychotherapy (≥1 session/month for >6 months), physical therapy (e.g., modified electroconvulsive therapy [MECT], repetitive transcranial magnetic stimulation [rTMS], transcranial direct current stimulation [tDCS], or deep brain stimulation [DBS]), or exercise therapy ;
   • Clinician-assessed suicide risk or a HAMD-17 item 3 score ≥3 at the baseline;
   • Presence of severe systemic or neurological conditions, such as diabetes, hypertension, renal failure, hepatic dysfunction, thyroid disorders, encephalitis, traumatic brain injury, or epilepsy;
   • Severe retinal pathologies (e.g., retinal detachment, optic atrophy, macular degeneration); or having high myopia (spherical equivalent ≤ -6.00 diopters);
   • Current use of photosensitizing agents or medications (e.g., chlorpromazine, hypericum extract);
   • Any other condition deemed inappropriate by the investigators(e.g., cases involving severe sleep phase delays that make morning therapy impossible, or unrecorded photosensitivity).

The inclusion and exclusion criteria for Health controls

1. Inclusion criteria

   • Aged 13-17 years and right-handed;
   • Minimum of 5 years of formal education, with the ability to complete clinical assessments and comprehend study-related information;
   • Voluntary participation with written informed consent provided by both participants and their legal guardians.

2. Exclusion criteria

   • Current or lifetime diagnosis of any psychiatric disorders (e.g., schizophrenia, mood disorders, anxiety disorders) or history of substance/drug abuse or dependence;
   • First-degree family history of psychiatric disorders;
   • Presence of severe systemic or neurological disorders, such as diabetes, hypertension, renal failure, hepatic dysfunction, thyroid disorders, encephalitis, traumatic brain injury, or epilepsy;
   • Any other condition deemed inappropriate by the investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bright light therapy（Light intensity is 10,000lux）; In this study, participants randomly assigned to the intervention group will receive bright white light therapy interventions with light intensities of 10000 lux. The intervention plan is to receive 40 minutes of light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 45cm from the light source.	Device: Bright light therapy（High light intensity）; In this study, we will utilize the optocoupler-controllable light source, a product jointly developed by the School of Physics at Peking University and Peking University Sixth Hospital, which granted a national patent in China, for the purpose of intervention. Participants randomly assigned to the high light density intervention group will receive bright white light therapy interventions with light intensities of 10000 lux, and the main wavelength of light source is 476.4nm. The intervention plan is to receive 40 minutes of light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.
Experimental: Bright light therapy（Light intensity is 5,000lux）; In this study, participants randomly assigned to the intervention group will receive bright white light therapy interventions with light intensities of 5000 lux. The intervention plan is to receive 40 minutes of light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.	Device: Bright light therapy（Low light intensity）; In this study, we will utilize the optocoupler-controllable light source, a product jointly developed by the School of Physics at Peking University and Peking University Sixth Hospital, which granted a national patent in China, for the purpose of intervention. Participants randomly assigned to the low light density intervention group will receive bright white light therapy interventions with light intensities of 5,000 lux,and the main wavelength of light source is 476.4nm. The intervention plan is to receive 40 minutes of light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.
Placebo Comparator: Dim red light control intervention; In this study, participants randomly assigned to the placebo-controlled group will receive dim red light therapy interventions with light intensities of 100 lux. The placebo-controlled intervention plan is to receive 40 minutes of red light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.	Device: Dim red light placebo-controlled intervention; In this study, participants randomly assigned to the placebo-controlled group will receive dim red light therapy interventions with light intensities of 100 lux, and the main wavelength of light source is 690.4nm. The placebo-controlled intervention plan is to receive 40 minutes of red light therapy from 6:30-10:00 in the morning for 4 consecutive weeks, 6 days a week. The subject sits at a distance of 60cm from the light source.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Rating Scale-17(HAMD-17)	The HAMD-17, developed by Hamilton in 1960, remains one of the most authoritative and widely utilized clinician-rated instruments for assessing depressive severity41. The Chinese version of the HAMD-17 has demonstrated satisfactory internal consistency (Cronbach's alpha = 0.714) and robust concurrent validity. The HAMD-17 assessment comprises 17 items; items 8, 9, and 11 are scored through structured behavioural observation, while the remaining items are primarily assessed via patient self-report during semi-structured interviews. Scoring utilized a five-point Likert scale for the majority of items (1-7, 10, 12-17), with exceptions employing a three-point scale for items 4-6 and 16. Total scores are derived from the summation of all item scores, with higher values indicating greater depressive severity.	baseline，7 days after the intervention begin，14 days after the intervention begin，21 days after the intervention begin，28 days after the intervention begin，7 days after the intervention accomplished，14 days after the intervention accomplished

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder-7(GAD-7)	The GAD-7, developed by Spitzer et al. in 2006, is a brief self-administered screening questionnaire evaluating the severity of anxiety symptoms. It consists of 7 items rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores reflecting greater anxiety severity. The Chinese version of the GAD-7 has demonstrated excellent psychometric properties, exhibiting robust internal consistency (Cronbach's α = 0.93-0.95) among large Chinese adolescent cohorts.	baseline，7 days after the intervention begin，14 days after the intervention begin，21 days after the intervention begin，28 days after the intervention begin，7 days after the intervention accomplished，14 days after the intervention accomplished
Quick Inventory of Depressive Symptomatology-Self-Report(QIDS-SR)	The QIDS-SR, first developed and validated by Rush and colleagues in 2003, is a DSM-IV-based self-report tool specifically designed to assess depressive symptomatology over a seven-day recall period42. The QIDS-SR16 has been validated as a reliable and effective instrument for adolescent outpatients, demonstrating high internal consistency and a robust unidimensional structure. It comprises 16 items, each rated on a 0-3 point scale, with higher total scores indicating greater severity of depressive symptoms. In this study, the QIDS-SR was used to assess self-reported depressive symptoms.	baseline， every day of the first two weeks after the intervention begin，21 days after the intervention begin，28 days after the intervention begin，7 days after the intervention accomplished，14 days after the intervention accomplished
Pittsburgh Sleep Quality Inventory (PSQI)	The PSQI, developed by Buysse et al. in 1989 at the University of Pittsburgh, is a self-rated questionnaire designed to assess sleep quality. The Chinese version of the PSQI, validated by Liu et al., demonstrated high internal consistency with a Cronbach's alpha of 0.84 and excellent test-retest reliability with an r value of 0.81 over a two-week period. It comprises nine items: the first four are open-ended, and the remaining five are multiple-choice, with Item 5 containing ten sub-items. These items collectively evaluate seven sleep components, each scored 0-3, yielding a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.	baseline，7 days after the intervention begin，14 days after the intervention begin，21 days after the intervention begin，28 days after the intervention begin，7 days after the intervention accomplished，14 days after the intervention accomplished
Hopkins Verbal Learning Test-Revised (HVLT-R)	HVLT-R is a widely used neuropsychological assessment tool designed to evaluate verbal memory and cognitive function. Developed by J. Brandt and Benedict in 2001, the HVLT-R consists of a list of 12 nouns divided into three semantic categories (e.g., dwelling places, four-legged animals, and precious stones), with four words per category. The assessment involves three learning trials, where participants are presented with the list of words and are asked to recall as many words as possible immediately after each presentation. Additionally, there is a delayed recall trial, where participants are asked to recall the words after a delay of 20-25 minutes. The scoring principle is based on the number of correctly recalled words during each learning trial and the delayed recall trial. The total scores of the three learning trials and the delayed recall trial were computed to represent verbal learning and memory function.	baseline, 14 days after the intervention begin, 28 days after the intervention begin，14 days after the intervention accomplished
Brief Visuospatial Memory Test-Revised (BVMT-R)	Brief Visuospatial Memory Test-Revised is a neuropsychological assessment tool designed to evaluate visual spatial memory. Developed by researchers including Barr, Morrison, Zaroff, and Devinsky in 2004, the BVMT-R consists of six geometric figures presented in a 2x3 array, serving as the stimuli for the test. The assessment involves three learning trials, where participants are shown the stimuli for 10 seconds and are then asked to draw as many of the figures as possible in the correct locations on a response sheet. After a delay of approximately 25 minutes, a delayed recall trial is administered, followed by a recognition trial where participants are asked to identify the original geometric figures among a set of 12. The scoring principle is based on the number of correctly recalled and recognized figures, reflecting participants' visuospatial memory ability.	baseline, 14 days after the intervention begin, 28 days after the intervention begin, 14 days after the intervention accomplished
Color Trails Test (CTT)	The Color Trails Test (CTT) is a neuropsychological assessment tool specifically designed to minimize cultural and linguistic biases by using colors instead of letters. The test consists of two parts: CTT-1 and CTT-2, each preceded by a brief practice session.; CTT-1: The examinee is required to connect circles numbered 1 through 25 in ascending order as quickly as possible. In this part, all circles are of a uniform color (typically yellow or pink). This part primarily assesses the examinee's psychomotor speed and visual scanning abilities.; CTT-2: This part consists of 50 circles, containing two sets of numbers from 1 to 25. Each number appears twice: once in a pink circle and once in a yellow circle. The examinee must connect the numbers in ascending order (1-2-3...) while simultaneously alternating between the two colors (e.g., 1-Pink, 2-Yellow, 3-Pink, 4-Yellow...). This part serves as a sensitive measure of sustained attention, divided attention, and cognitive flexibility.	baseline，14 days after the intervention begin，28 days after the intervention begin，14 days after the intervention accomplished
The General Self-Efficacy Scale (GSES)	The GSES, based on Bandura's self-efficacy theory, originally developed by Schwarzer and Jerusalem in 1981, and revised for the Chinese population by Wang et al., evaluates an individual's perceived ability to cope with setbacks or challenges. It comprises 10 items rated on a 4-point Likert scale (1-4), with total scores ranging from 10 to 40; higher scores indicate greater self-efficacy.	baseline, 7 days after the intervention begin, 14 days after the intervention begin, 21 days after the intervention begin, 28 days after the intervention begin, 7 days after the intervention accomplished, 14 days after the intervention accomplished
Young Mania Rating Scale (YMRS)	Developed by Young et al. in 1978, the YMRS is a widely utilized clinician-administered tool designed to quantify the severity of manic symptoms. It comprises 11 items evaluating domains such as mood elevation, increased motor activity, irritability, speech, thought content, and sleep disturbance. Four items (irritability, speech, thought content, and disruptive/aggressive behavior) are graded on a 0 to 8 Likert scale to capture a broader range of severity, while the remaining seven items are graded on a 0 to 4 scale. Total scores range from 0 to 60, with higher scores indicating greater manic severity.	baseline, 7 days after the intervention begin, 14 days after the intervention begin, 21 days after the intervention begin, 28 days after the intervention begin, 7 days after the intervention accomplished, 14 days after the intervention accomplished
Asberg Side-Effect Rating Scale for Antidepressants(SERS)	Originally introduced by Åsberg et al. in 1978, the Side Effects Rating Scale (SERS) is a standardized instrument employed to assess the burden of common antidepressant-induced adverse events. Each SERS item is rated on a 0-3-point scale with the following criteria: (0) absent; (1) mild; (2) moderate; (3) severe. Outcome measures include individual item scores and total scores, with higher scores indicating greater side effect severity. This study utilized the SERS to assess both the alleviation of somatic symptoms and the potential adverse effects associated with the light therapy intervention.	baseline, 7 days after the intervention begin, 14 days after the intervention begin, 21 days after the intervention begin, 28 days after the intervention begin, 7 days after the intervention accomplished, 14 days after the intervention accomplished
Adolescent Irritability Rating Scale (ARI)	Developed by Stringaris et al. in 2012 to measure irritability in youths, the ARI evaluates the threshold, frequency, and duration of irritable manifestations. The 7-item scale is rated from 0 (not true) to 2 (certainly true). The total score is the sum of the first six items, while the seventh item independently assesses impairment. The Chinese adaptation of the ARI has demonstrated good convergent and concurrent validity, alongside robust reliability among adolescents.	baseline, 7 days after the intervention begin, 14 days after the intervention begin, 21 days after the intervention begin, 28 days after the intervention begin, 7 days after the intervention accomplished, 14 days after the intervention accomplished
Stroop Color-Word Test (SCWT)	The SCWT was developed by Professor Stroop in 1935 to evaluate subjects' executive functions. The test is a measure of selective attention and the degree of inhibition of irrelevant information in executive functioning. It consists of three main parts: reading words (Stroop-w), color naming (Stroop-c), and color-word interference (Stroop-cw), which require subjects to accurately and quickly read the words or the colors, respectively, as required.	baseline, 14 days after the intervention begin, 28 days after the intervention begin, 14 days after the intervention accomplished
Ottawa Self-Injury Inventory (OSI)	Developed by Nixon and Cloutier in the late 1990s, the OSI comprehensively assesses non-suicidal self-injury (NSSI) behaviors and addictive features. The Chinese OSI demonstrated favorable reliability and validity in adolescent cohorts. NSSI frequency over the past month is scored on a 4-point scale, whereas longer-term frequencies (e.g., past 6 months, past year) use a 5-point scale. In this study, the OSI items were employed to evaluate NSSI/suicide attempt frequency, severity, history, onset age, emotional triggers, and disclosure.	baseline, 7 days after the intervention begin, 14 days after the intervention begin, 21 days after the intervention begin, 28 days after the intervention begin, 7 days after the intervention accomplished, 14 days after the intervention accomplished
Response rate	Response will be defined as a ≥50% reduction in the total score of the HAMD-17 from baseline.	baseline, 28 days after the intervention begin
Remission rate	Remission will be defined as achieving a HAMD-17 score of ≤7 points at T4.	28 days after the intervention begin
Hamilton Anxiety Rating Scale (HAMA)	Originally developed by Hamilton in 195944, the HAMA is a classic clinician-administered questionnaire assessing both somatic and psychic anxiety severity. The 14-item instrument captures psychic anxiety (items 1-6, 14) and somatic anxiety (items 7-13). Each item is rated on a 5-point Likert scale from 0 (absent) to 4 (very severe), with higher total scores indicating more severe clinical anxiety. The construct validity and reliability of the Chinese HAMA adaptation have been rigorously established in domestic psychometric studies.In this study, the HAMA was used to assess the severity of anxiety symptoms.	baseline，7 days after the intervention begin，14 days after the intervention begin，21 days after the intervention begin，28 days after the intervention begin，7 days after the intervention accomplished，14 days after the intervention accomplished
Sleep diary	The sleep diary used in this study was adapted from the National Sleep Foundation Sleep Diary (MSFSD) and consists of two sections: morning and evening entries. Morning entries assess bedtime, wake-up time, sleep latency, number of nocturnal awakenings, subjective morning alertness, total sleep duration, and factors disrupting sleep. Evening entries assess daytime nap frequency and duration, physical activity and outdoor exposure, caffeine intake, pre-sleep dietary intake and hydration, electronic device usage before bedtime, and activities during the hour preceding sleep.	Recorded daily during the intervention
Semi-structured interviews	Each interview will last around 30 minutes and will be conducted via secure videoconferencing platforms. The interview guide will explore participants' experiences with home-based BLT, including perceived impacts on daily life, expectations of treatment efficacy, attitudes toward home-based delivery, and willingness to recommend BLT to adolescents with similar needs.Semi-structured interviews were used to assess the applicability of BLT.	After the intervention period.
fNIRS indicators	During the resting-state recording, subjects will be instructed to keep their eyes open, remain awake, maintain a relaxed state, and refrain from engaging in thoughts that could influence their mood. In each run, eight minutes of resting-state fNIRS data are acquired. The experimental task was based on a standardized Chinese VFT paradigm and comprised three phases: a 30-second baseline rest, a 60-second active word-generation period, and a 70-second recovery phase53. During the rest phases, participants were instructed to fixate on a central point while counting aloud from 1 to 5. During the task, participants are instructed to generate compound words using the Chinese characters '白' (white), '天' (sky), and '大' (big), which are presented sequentially. Resting-state functional connectivity and task-related cortical activation levels were extracted as outcome measures.	baseline, 28 days after the intervention begin
the Continuous Performance Test-Identical Pairs (CPT-IP)	The CPT-IP was administered using the CBCT software. Participants were instructed to press the response key as quickly as possible when specific "target stimuli"-i.e., animal pictures-appeared on the screen. When distractor stimuli were presented, participants were required to withhold their keypress response. This test is primarily used to assess participants' sustained attention, vigilance, and impulse control.	baseline, 14 days after the intervention begin, 28 days after the intervention begin, 14 days after the intervention accomplished
Trail Making Test Part A (TMT-A)	The Trail Making Test Part A (TMT-A) requires the examinee to connect 25 randomly distributed circles in ascending numerical order (1-2-3...) as quickly as possible without lifting the pen, serving as a standardized measure of visual scanning, psychomotor speed, and motor coordination.	baseline, 14 days after the intervention begin, 28 days after the intervention begin, 14 days after the intervention accomplished

Collaborators and Investigators

• Sponsor: Peking University Sixth Hospital
• Collaborators: Beijing HuiLongGuan Hospital; Yan'an Third People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 30, 2025
• First Submitted That Met QC Criteria: March 30, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Adolescent; Randomised Controlled Trial; Bright Light Therapy; Neural Mechanisms; Depressive Disorder，Major
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: BRWEP2024W074110106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As the research is still in the recruitment stage and has not yet reached the data analysis phase, no usable dataset has been generated yet. De-identified individual participant data (IPD) underlying the results reported in this article will be available beginning 6 to 12 months after publication.
• IPD Sharing Time Frame: Data will become available 6 to 12 months after the publication of the primary trial results and will remain accessible for up to 2 years (24 months).

IPD Sharing Access Criteria

Eligible Applicants: Access will be granted to qualified researchers who provide a methodologically sound research proposal and whose request has been approved by the study's Primary Investigators or an independent review committee.

Purpose of Data Sharing: The data will be shared to facilitate the achievement of scientific objectives specified in the approved research proposal.

Application Process and Workflow:

Submission of Proposal: Interested applicants are required to submit a formal research proposal and a Statistical Analysis Plan (SAP) to the corresponding author via email at lvxiaozhen@bjmu.edu.cn.

Review and Agreement: Upon approval of the proposal, the data requestor must sign a formal Data Access Agreement (DAA). this agreement ensures strict compliance with data security, ethical standards, and participant privacy protections.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No