Investigation of Seasonal Variations of Brain Structure and Connectivity in SAD

Not Applicable

Completed

• Conditions: Neuroimaging; Seasonal Affective Disorder; Major Depressive Disorder
• Interventions: Device: Bright Light Therapy

• Registration Number: NCT03313674
• Lead Sponsor: Sunnybrook Health Sciences Centre

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-18
• Study Start: 2017-11-01
• Primary Completion: 2019-10-05
• Study Completion: 2019-10-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seasonal Affective Disorder	Bright Light Therapy	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

Primary Outcome Measures

Name	Time	Method
Changes in neural function	12 months	Functional MRI Scan
Changes in connectivity	12 months	Diffusion Tensor Imaging Scan

Secondary Outcome Measures

Name	Time	Method
Memory	12 months	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.
Blood Serum Metabolomic seasonal variation	12 months	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.
Depressive severity measured through the • Structured Interview Guide for the Hamilton Depression Rating Scale-SAD version	12 months	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.
Executive Function	12 months	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
Concentration	12 months	Digit Symbol Substitute Test will be used to measure concentration. Survey score is determined by the number of correct and incorrect responses

Trial Locations

Locations (1)

Sunnybrook Health Science Centre; 🇨🇦 Toronto, Ontario, Canada