Phototherapy in Young People With Depression

Not Applicable

• Conditions: Depression
• Interventions: Device: Phototherapy light-emitting glasses

• Registration Number: NCT02448433
• Lead Sponsor: University of Ottawa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Status Verified: 2015-05
• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-05-14
• Last Update Submitted: 2015-05-14
• Study First Posted: 2015-05-19
• Last Update Posted: 2015-05-19
• Primary Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Quick Inventory of Depressive Symptomatology score > 6;
2. First episode of depression before age 25;
3. Currently engaged in, or about to start treatment for an affective disorder at a mental health clinic.

Exclusion Criteria

1. Evidence of other sleep, neurological or primary medical conditions that could explain the current depression and/or contribute to sleep-wake dysfunction;
2. Other primary psychiatric disorders aside from anxiety disorders;
3. Significant alcohol or other substance dependence;
4. 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);
5. Use of medications that may interact with light to produce a photoallergic reaction;
6. Eye or skin condition which may interact with bright light exposure;
7. Regular shift-work within 60-days prior to entry into the study;
8. Recent transmeridian travel.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phototherapy	Phototherapy light-emitting glasses	-

Primary Outcome Measures

Name	Time	Method
Severity of Depression	Between baseline and post (4 weeks) intervention	Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)

Secondary Outcome Measures

Name	Time	Method
Severity of Depression	Score between baseline and follow up (8 weeks)	Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Associations between Changes in Sleep-Wake Profile and Changes in Severity of Depression	Between baseline and post (4 weeks) intervention	Associations between changes in sleep-wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Associations between Initial Sleep-Wake Profile and Changes in Severity of Depression	Baseline and post (4 weeks) intervention	Associations between the initial sleep-wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Subjective Sleep Quality	Between baseline and post (4 weeks) intervention	Change in Leeds Sleep Evaluation Questionnaire score
Fatigue Severity	Between baseline and post (4 weeks) intervention	Change in Fatigue Severity Scale score

Trial Locations

Locations (2)

Brain and Mind Research Insitute, The University of Sydney; 🇦🇺 Camperdown, New South Wales, Australia

Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa; 🇨🇦 Ottawa, Ontario, Canada