Phototherapy in Young People With Depression

Depression Clinical Trial

Official title:

Phototherapy in Young People With Depression; Investigating Associations Between Changes in Actigraphic Sleep-wake Profile and Depressive Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02448433
• Other study ID #: 2015007
• Status: Recruiting
• Phase: N/A
• First received: May 14, 2015
• Last updated: May 14, 2015
• Start date: April 2015

Study information

• Verified date: May 2015
• Source: University of Ottawa
• Contact: Rébecca Robillard, PhD
• Phone: +1 613 722 6521
• Email: reb.robillard[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 30 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Phototherapy light-emitting glasses
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.

Locations

Country	Name	City	State
Australia	Brain and Mind Research Insitute, The University of Sydney	Camperdown	New South Wales
Canada	Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Ottawa	University of Sydney

Countries where clinical trial is conducted

Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Severity of Depression	Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)	Score between baseline and follow up (8 weeks)	No
Secondary	Associations between Changes in Sleep-Wake Profile and Changes in Severity of Depression	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)	Between baseline and post (4 weeks) intervention	No
Secondary	Associations between Initial Sleep-Wake Profile and Changes in Severity of Depression	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)	Baseline and post (4 weeks) intervention	No
Secondary	Subjective Sleep Quality	Change in Leeds Sleep Evaluation Questionnaire score	Between baseline and post (4 weeks) intervention	No
Secondary	Fatigue Severity	Change in Fatigue Severity Scale score	Between baseline and post (4 weeks) intervention	No