DepressionNCT02448433
Phototherapy in Young People With Depression
A study testing Phototherapy light-emitting glasses in people with Depression, run by University of Ottawa at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 13 to 30 years
- Conditions the study is for
- Depression
- What is being tested?
- Phototherapy light-emitting glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
- Suspended
Brain and Mind Research Insitute, The University of Sydney
Camperdown, New South Wales, 2050
Canada1 site, 1 recruiting
- Recruiting
Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa
Ottawa, Ontario, K1Z 7K4
Rébecca Robillard, PhD, +1 613 722 6521 ext. 6279, reb.robillard@gmail.com
About this study
Official title: Phototherapy in Young People With Depression; Investigating Associations Between Changes in Actigraphic Sleep-wake Profile and Depressive Symptoms
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
- Being tested
- Phototherapy light-emitting glasses
- Keywords
- Phototherapy, Light, Depression, Sleep and circadian disturbances, Youth
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phototherapy light-emitting glassesDevice
Also called Re-timer
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.
| Study group | Role | What they receive |
|---|---|---|
| Phototherapy | Other | Not described Receives: Device: Phototherapy light-emitting glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Depression
Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Measured: Between baseline and post (4 weeks) intervention
Secondary outcomes (5)
Severity of Depression
Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Measured: Score between baseline and follow up (8 weeks)
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)
Measured: Between baseline and post (4 weeks) intervention
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)
Measured: Baseline and post (4 weeks) intervention
Subjective Sleep Quality
Change in Leeds Sleep Evaluation Questionnaire score
Measured: Between baseline and post (4 weeks) intervention
Fatigue Severity
Change in Fatigue Severity Scale score
Measured: Between baseline and post (4 weeks) intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney
- Responsible party
- Principal investigator, Rébecca Robillard, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448433
- Sponsor's protocol ID
- 2015007
- Status last verified
- May 2015
- First submitted
- 14 May 2015
- Last updated
- 19 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phototherapy in Young People With Depression; Investigating Associations Between Changes in Actigraphic Sleep-wake Profile and Depressive Symptoms
- ClinicalTrials.gov ID
- NCT02448433
- Acronym / sponsor ID
- 2015007
- Conditions
- Depression
- Keywords
- Phototherapy, Light, Depression, Sleep and circadian disturbances, Youth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- University of Sydney
- Study start
- Apr 2015
- Primary completion
- Apr 2017 (estimated)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phototherapy | Other | Device: Phototherapy light-emitting glasses |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phototherapy light-emitting glassesAlso: Re-timerThe 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. | Device | Phototherapy |
Primary outcome
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)
5 secondary outcomes
Severity of Depression
Time frame: Score between baseline and follow up (8 weeks)
Associations between Changes in Sleep-Wake Profile and Changes in Severity of Depression
Time frame: Between baseline and post (4 weeks) intervention
Associations between Initial Sleep-Wake Profile and Changes in Severity of Depression
Time frame: Baseline and post (4 weeks) intervention
Subjective Sleep Quality
Time frame: Between baseline and post (4 weeks) intervention
Fatigue Severity
Time frame: Between baseline and post (4 weeks) intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phototherapy light-emitting glasses in people with Depression, run by University of Ottawa at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rébecca Robillard, PhD (+1 613 722 6521 ext. 6279, reb.robillard@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Depression (time frame: Between baseline and post (4 weeks) intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015.