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Phototherapy in Young People With Depression

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ClinicalTrials.gov Identifier: NCT02448433
Recruitment Status : Unknown
Verified May 2015 by Rébecca Robillard, University of Ottawa.
Recruitment status was:  Recruiting
First Posted : May 19, 2015
Last Update Posted : May 19, 2015
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
Rébecca Robillard, 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.


Condition or disease Intervention/treatment Phase
Depression Device: Phototherapy light-emitting glasses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phototherapy in Young People With Depression; Investigating Associations Between Changes in Actigraphic Sleep-wake Profile and Depressive Symptoms
Study Start Date : April 2015
Estimated Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Phototherapy 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.

Other Name: Re-timer




Primary Outcome Measures :
  1. Severity of Depression [ Time Frame: 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 :
  1. Severity of Depression [ Time Frame: Score between baseline and follow up (8 weeks) ]
    Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)

  2. Associations between Changes in Sleep-Wake Profile and Changes in Severity of Depression [ Time Frame: 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)

  3. Associations between Initial Sleep-Wake Profile and Changes in Severity of Depression [ Time Frame: 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)

  4. Subjective Sleep Quality [ Time Frame: Between baseline and post (4 weeks) intervention ]
    Change in Leeds Sleep Evaluation Questionnaire score

  5. Fatigue Severity [ Time Frame: Between baseline and post (4 weeks) intervention ]
    Change in Fatigue Severity Scale score



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Ages Eligible for Study:   13 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448433


Contacts
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Contact: Rébecca Robillard, PhD +1 613 722 6521 ext 6279 reb.robillard@gmail.com

Locations
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Australia, New South Wales
Brain and Mind Research Insitute, The University of Sydney Suspended
Camperdown, New South Wales, Australia, 2050
Canada, Ontario
Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa Recruiting
Ottawa, Ontario, Canada, K1Z 7K4
Contact: Rébecca Robillard, PhD    +1 613 722 6521 ext 6279    reb.robillard@gmail.com   
Sponsors and Collaborators
University of Ottawa
University of Sydney

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Responsible Party: Rébecca Robillard, Research Fellow, University of Ottawa
ClinicalTrials.gov Identifier: NCT02448433     History of Changes
Other Study ID Numbers: 2015007
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015

Keywords provided by Rébecca Robillard, University of Ottawa:
Phototherapy
Light
Depression
Sleep and circadian disturbances
Youth

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders