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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02448433




Registration number
NCT02448433
Ethics application status
Date submitted
14/05/2015
Date registered
19/05/2015
Date last updated
19/05/2015

Titles & IDs
Public title
Phototherapy in Young People With Depression
Scientific title
Phototherapy in Young People With Depression; Investigating Associations Between Changes in Actigraphic Sleep-wake Profile and Depressive Symptoms
Secondary ID [1] 0 0
2015007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Phototherapy light-emitting glasses

Other: Phototherapy -


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Severity of Depression - Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Timepoint [1] 0 0
Between baseline and post (4 weeks) intervention
Secondary outcome [1] 0 0
Severity of Depression - Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Timepoint [1] 0 0
Score between baseline and follow up (8 weeks)
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
Between baseline and post (4 weeks) intervention
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
Baseline and post (4 weeks) intervention
Secondary outcome [4] 0 0
Subjective Sleep Quality - Change in Leeds Sleep Evaluation Questionnaire score
Timepoint [4] 0 0
Between baseline and post (4 weeks) intervention
Secondary outcome [5] 0 0
Fatigue Severity - Change in Fatigue Severity Scale score
Timepoint [5] 0 0
Between baseline and post (4 weeks) intervention

Eligibility
Key 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.
Minimum age
13 Years
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Brain and Mind Research Insitute, The University of Sydney - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
University of Ottawa
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02448433
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rébecca Robillard, PhD
Address 0 0
Country 0 0
Phone 0 0
+1 613 722 6521
Fax 0 0
Email 0 0
reb.robillard@gmail.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02448433