Phototherapy in Young People With Depression
1 other identifier
interventional
60
2 countries
2
Brief Summary
Bright light therapy is an established treatment pathway for sleep and circadian disorders and evidence suggests that it has antidepressant effects. The underlying mechanisms of these antidepressant effects are not fully understood and results from previous studies are somewhat variable. One of the important limitations of previous depression studies has been the heterogeneity of samples in which bright light therapy has been administered. The main aim of this study is to evaluate whether the antidepressant effects of phototherapy in young persons with depression are modulated by changes in the sleep-wake cycle. We hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant response to phototherapy and that the magnitude of changes in depressive symptoms across the course of the intervention will correlate with changes in the sleep-wake cycle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 14, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedMay 19, 2015
May 1, 2015
2 years
May 14, 2015
May 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severity of Depression
Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Between baseline and post (4 weeks) intervention
Secondary Outcomes (5)
Severity of Depression
Score between baseline and follow up (8 weeks)
Associations between Changes in Sleep-Wake Profile and Changes in Severity of Depression
Between baseline and post (4 weeks) intervention
Associations between Initial Sleep-Wake Profile and Changes in Severity of Depression
Baseline and post (4 weeks) intervention
Subjective Sleep Quality
Between baseline and post (4 weeks) intervention
Fatigue Severity
Between baseline and post (4 weeks) intervention
Study Arms (1)
Phototherapy
OTHERInterventions
The intervention consists of four weeks of bright light exposure with light-emitting glasses (blue-green 500 nm dominant wavelength; 506 Lux lm/m\^2) upon awakening and progressive shift to earlier wake-up times. Participants are encouraged to complete the light exposure sessions for 60 min each day. Participants are also instructed to progressively shift their schedule 15 min earlier every day. This shift continues until the end of the four weeks of the intervention, or stops if the target wake-up time of 7:30am is reached (in which case, participants keep a stable wake-up and light session schedule at 7.30am for the remainder of the intervention). If participants already wake-up before 7.30am at study entry, they do the light exposure sessions upon awakening across the four weeks of the intervention. During the intervention, participants are asked to note down the time of each light exposure session in a diary. Adherence is also monitored and promoted through weekly phone calls.
Eligibility Criteria
You may qualify if:
- Quick Inventory of Depressive Symptomatology score \> 6;
- First episode of depression before age 25;
- Currently engaged in, or about to start treatment for an affective disorder at a mental health clinic.
You may not qualify if:
- Evidence of other sleep, neurological or primary medical conditions that could explain the current depression and/or contribute to sleep-wake dysfunction;
- Other primary psychiatric disorders aside from anxiety disorders;
- Significant alcohol or other substance dependence;
- Use of medications that affect sleep, circadian rhythms, or alertness within the past month (participants stabilized on an antidepressant medication, stimulants, lithium or melatoninergic agents will not be excluded from the study);
- Use of medications that may interact with light to produce a photoallergic reaction;
- Eye or skin condition which may interact with bright light exposure;
- Regular shift-work within 60-days prior to entry into the study;
- Recent transmeridian travel.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Ottawalead
- University of Sydneycollaborator
Study Sites (2)
Brain and Mind Research Insitute, The University of Sydney
Camperdown, New South Wales, 2050, Australia
Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa
Ottawa, Ontario, K1Z 7K4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Fellow
Study Record Dates
First Submitted
May 14, 2015
First Posted
May 19, 2015
Study Start
April 1, 2015
Primary Completion
April 1, 2017
Last Updated
May 19, 2015
Record last verified: 2015-05