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Phototherapy in Young People With Depression

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Phototherapy light-emitting glasses
Sponsored by
University of Ottawa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Phototherapy, Light, Depression, Sleep and circadian disturbances, Youth

Eligibility Criteria

13 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brain and Mind Research Insitute, The University of Sydney
  • Sleep and Depression Research Units, Institute of Mental Health Research, University of OttawaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Phototherapy

Arm Description

Outcomes

Primary Outcome Measures

Severity of Depression
Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)

Secondary Outcome Measures

Severity of Depression
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
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
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
Change in Leeds Sleep Evaluation Questionnaire score
Fatigue Severity
Change in Fatigue Severity Scale score

Full Information

First Posted
May 14, 2015
Last Updated
May 14, 2015
Sponsor
University of Ottawa
Collaborators
University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT02448433
Brief Title
Phototherapy in Young People With Depression
Official Title
Phototherapy in Young People With Depression; Investigating Associations Between Changes in Actigraphic Sleep-wake Profile and Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ottawa
Collaborators
University of Sydney

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Phototherapy, Light, Depression, Sleep and circadian disturbances, Youth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phototherapy
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Phototherapy light-emitting glasses
Other Intervention Name(s)
Re-timer
Intervention Description
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 Information:
Title
Severity of Depression
Description
Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Time Frame
Between baseline and post (4 weeks) intervention
Secondary Outcome Measure Information:
Title
Severity of Depression
Description
Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Time Frame
Score between baseline and follow up (8 weeks)
Title
Associations between Changes in Sleep-Wake Profile and Changes in Severity of Depression
Description
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)
Time Frame
Between baseline and post (4 weeks) intervention
Title
Associations between Initial Sleep-Wake Profile and Changes in Severity of Depression
Description
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)
Time Frame
Baseline and post (4 weeks) intervention
Title
Subjective Sleep Quality
Description
Change in Leeds Sleep Evaluation Questionnaire score
Time Frame
Between baseline and post (4 weeks) intervention
Title
Fatigue Severity
Description
Change in Fatigue Severity Scale score
Time Frame
Between baseline and post (4 weeks) intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rébecca Robillard, PhD
Phone
+1 613 722 6521
Ext
6279
Email
reb.robillard@gmail.com
Facility Information:
Facility Name
Brain and Mind Research Insitute, The University of Sydney
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Suspended
Facility Name
Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 7K4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rébecca Robillard, PhD
Phone
+1 613 722 6521
Ext
6279
Email
reb.robillard@gmail.com

12. IPD Sharing Statement

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Phototherapy in Young People With Depression

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