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Investigation of Seasonal Variations of Brain Structure and Connectivity in SAD

Seasonal Affective Disorder: Exploratory Investigation of Seasonal Variations in Brain Structure and Connectivity as a Predictor for Depressive Severity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03313674
Enrollment
23
Registered
2017-10-18
Start date
2017-11-01
Completion date
2019-10-05
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder, Neuroimaging, Seasonal Affective Disorder

Brief 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).

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

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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. DSM-V 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. Montreal Cognitive Assessment score \< 24 8. Patients with standard contraindications 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 glomerular filtration rate \<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

Design outcomes

Primary

MeasureTime frameDescription
Changes in connectivity12 monthsDiffusion Tensor Imaging Scan
Changes in neural function12 monthsFunctional MRI Scan

Secondary

MeasureTime frameDescription
Memory12 monthsCalifornia Verbal Learning Test. Score is conducted based on a propriety software based on the number of correctly recalled words after a list is administrated.
Executive Function12 monthsTrail 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
Depressive severity measured through the • Structured Interview Guide for the Hamilton Depression Rating Scale-SAD version12 monthsSigh-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.
Blood Serum Metabolomic seasonal variation12 monthsBlood 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.
Concentration12 monthsDigit Symbol Substitute Test will be used to measure concentration. Survey score is determined by the number of correct and incorrect responses

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026