ClinicalTrials.gg
CompletedNCT03313674Updated Mar 16, 2021

Investigation of Seasonal Variations of Brain Structure and Connectivity in SAD

An interventional study of Bright Light Therapy in Seasonal Affective Disorder, Major Depressive Disorder and Neuroimaging, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-16.

Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Diagnostic

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Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Seasonal Affective Disorder (SAD) is a subtype of Major Depressive Disorder, characterized by a recurrent temporal relationship between the season of year, the onset and the remission of a major depressive episode. Estimates of the annual prevalence state that 1-6% of the population will develop SAD with the larger prevalences found at greater extremes in latitude. SAD is most likely triggered by the shortening photoperiod experienced in the winter months leading to a deterioration of mood. Recent cross-sectional neuroimaging studies have found cellular and neurotransmitter changes in response to seasonality, ultimately having an impact on the affect of patients. Conversly, this study aims to investigate the changes in neurocircuitry related to depression and euthymic states. Patients with SAD offer a unique ability to study these changes since they have predictable triggers for the onset of depression (i.e. the winter months) and remission (i.e. the summer months).

02

Conditions studied

  • Seasonal Affective Disorder
  • Major Depressive Disorder
  • Neuroimaging
03

In context

Seasonal Affective Disorder

31 studies on the registry are indexed under Seasonal Affective Disorder; 2 are open to participants now.

This study's enrollment of 23 is below the median of 60 across 25 interventional studies indexed under Seasonal Affective Disorder.

Browse Seasonal Affective Disorder studies →

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria for SAD Cohort

  1. Male or female between the ages of 18 to 65 years, inclusive
  2. Patients who are able and willing to give consent and able to attend study visits
  3. Agreement to use light therapy for four weeks
  4. diagnosis of seasonal affective disorder, at least 2 year history of the illness with a Structured Interview Guide for the Hamilton Depression Rating Scale-SAD version (SIGH-SAD) score ≥ 25 at screening

Exclusion Criteria for SAD Cohort

  1. Current alcohol and/or substance use disorder
  2. Use of cigarettes
  3. Past or present psychiatric disorders (axis I and II) other than SAD
  4. Taken medications approved and/or employed off-label for depression
  5. Previous use of light therapy
  6. Use of photosensitive medications
  7. score \< 24
  8. Patients with standard for MR imaging. For example, non-MRI compatible metallic implants including cardiac pacemaker, size limitations etc.
  9. Known intolerance or allergies to MRI contrast agent (Gadolinium or Magnevist) including advanced kidney disease
  10. Severely impaired renal function (estimated \<30ml/min/1.73m2)
  11. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
  12. Pregnant and/or breastfeeding
  13. Travelled to another a more southern latitude within 6 months of scan
  14. Night shift workers
  15. Are participating or have participated in clinical trial or research study in the last 30 days
  16. Unable to communicate with investigator and/or staff
  17. Diagnosis of a reading disability, dyslexia or significant learning disorder

Inclusion Criteria for Unipolar Depression Cohort contraindications

  1. Male or female between the ages of 18 to 65 years, inclusive
  2. Patients who are able and willing to give consent and able to attend study visits
  3. DSM-V diagnosis of major depressive disorder, with a Hamilton Depression Rating Scale score ≥ 22 at screening

Exclusion Criteria for Unipolar Depression Cohort

  1. Current alcohol and/or substance use disorder
  2. Past or present psychiatric disorders (axis I and II) other than SAD
  3. Montreal Cognitive Assessment score \< 24
  4. Patients with standard contraindications for MR imaging. For example, non-MRI compatible metallic implants including cardiac pacemaker, size limitations etc.
  5. Known intolerance or allergies to MRI contrast agent (Gadolinium or Magnevist) including advanced kidney disease
  6. Severely impaired renal function (estimated glomerular filtration rate \<30ml/min/1.73m2)
  7. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
  8. Pregnant and/or breastfeeding
  9. Are participating or have participated in clinical trial or research study in the last 30 days
  10. Unable to communicate with investigator and/or staff
  11. Diagnosis of a reading disability, dyslexia or significant learning disorder

Inclusion Criteria for Healthy Controls

  1. Male or female between the ages of 18 to 65 years, inclusive
  2. Patients who are able and willing to give consent and able to attend study visits
  3. No current or past history of mental disorder
  4. No unstable medical disorders

Exclusion Criteria for Healthy Controls

  1. Use of any medication for a general medical disorder and/or condition that, in the opinion of the investigator, may affect neural structure
  2. Alcohol or drug-use within 24 hours of MRI
  3. Pregnant and/or breastfeeding
  4. Montreal Cognitive Assessment score \< 24
  5. Patients with standard contraindications for MR imaging. For example, non-MRI compatible metallic implants including cardiac pacemaker, size limitations etc.
  6. Known intolerance or allergies to MRI contrast agent (Gadolinium or Magnevist)
  7. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
  8. Are participating or have participated in clinical trial or research study in the last 30 days
  9. Unable to communicate with investigator and/or staff
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Seasonal Affective Disorder

    The primary objective is to use neuroimaging paradigms to identify perturbations in neural circuits of SAD patients when they are clinically depressed in the winter, after bright light therapy treatment, and when they are healthy in the summer

    Device: Bright Light Therapy

  • No intervention
    Major Depressive Disorder

    SAD patients will be compared to unipolar depressed patient cohort, who will be imaged in the winter and the summer.

  • No intervention
    Healthy Controls

    SAD patients will be compared to healthy controls, who will be imaged in the winter and the summer.

Interventions

  • DeviceBright Light Therapy

    Light box that emits light at 10,000 lux or higher and has been demonstrated to regulate circadian rhythm that is aberrant in the SAD population

06

What researchers measure

Primary outcomes

  1. Changes in neural function

    Functional MRI Scan

    Time frame: 12 months

  2. Changes in connectivity

    Diffusion Tensor Imaging Scan

    Time frame: 12 months

Secondary outcomes

  1. Executive Function

    Trail Makers Test B will be used to measure executive function. Test is scored based on time to complete.Average time is 75 seconds, deficient time is \>273 seconds

    Time frame: 12 months

  2. Concentration

    Digit Symbol Substitute Test will be used to measure concentration. Survey score is determined by the number of correct and incorrect responses

    Time frame: 12 months

  3. Memory

    California Verbal Learning Test. Score is conducted based on a propriety software based on the number of correctly recalled words after a list is administrated.

    Time frame: 12 months

  4. Blood Serum Metabolomic seasonal variation

    Blood will be drawn to assess different serum metabolites depending on the season. One blood draw will be taken in Winter, one in the summer. Over 3300 metabolites will be acquired from a single sample.

    Time frame: 12 months

  5. Depressive severity measured through the • Structured Interview Guide for the Hamilton Depression Rating Scale-SAD version

    Sigh-SAD measures Depressive Severity specifically in SAD patients. It contains 29 items, with the total score ranging from 0 to 29. Higher values in the scale indicate worse depression severity. Of the 29 items, 21 question (adapted from the Hamilton Depression scale) are used to determine typical depression severity, with an additional eight items for the "atypical" symptoms which are presented in seasonal affective disorder. The final score is summed, with equal weighting, to give the total score.

    Time frame: 12 months

07

Study locations

1 site
  • Sunnybrook Health Science Centre
    Toronto, Ontario M4N 3M5, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Oct 2019, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2017
First posted
Oct 18, 2017
StartActual
Nov 1, 2017
Primary completionActual
Oct 5, 2019
CompletionActual
Oct 5, 2019
Last update
Mar 16, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03313674
Responsible party
Dr. Nir Lipsman (Neurosurgeon, Scientist, Sunnybrook Health Sciences Centre) — Principal investigator
First posted
Oct 18, 2017
Start date
Nov 1, 2017
Primary completion
Oct 5, 2019
Completion
Oct 5, 2019
Last update
Mar 16, 2021

Study contacts

Nir Lipsman, MD PhD
principal investigator · Sunnybrook Health Sciences Centre

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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