Recruiting

Phototherapy

Sponsor:

University of Ottawa

Code:

NCT02448433

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 13 - 30

Healthy Volunteers: Not accepted

Interventions

Phototherapy light-emitting glasses

Study Details

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.

Conditions

Depression

Study ID

NCT02448433

Start date

Apr, 2015

Status verified date

May, 2015

Primary completion date

Apr, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 30

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Phototherapy

Interventions

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.

Primary outcome measure

  • Severity of Depression [ Time Frame: Between baseline and post (4 weeks) intervention ]

Central Contacts and Locations

Central contacts

Rébecca Robillard, PhD

+1 613 722 6521reb.robillard@gmail.com

Locations

Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa

Recruiting

Ottawa, Ontario, Canada, K1Z 7K4

Contacts

Rébecca Robillard, PhD

+1 613 722 6521reb.robillard@gmail.com

More Information

Sponsor

University of Ottawa

Last update posted

May 19, 2015

Last verified

May, 2015

Keywords

  • Phototherapy
  • Light
  • Depression
  • Sleep and circadian disturbances
  • Youth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2015-05-19.