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Investigation of Seasonal Variations of Brain Structure and Connectivity in SAD

Primary Purpose

Seasonal Affective Disorder, Major Depressive Disorder, Neuroimaging

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bright Light Therapy
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Seasonal Affective Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

Sites / Locations

  • Sunnybrook Health Science Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Seasonal Affective Disorder

Major Depressive Disorder

Healthy Controls

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Changes in neural function
Functional MRI Scan
Changes in connectivity
Diffusion Tensor Imaging Scan

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2017
Last Updated
March 15, 2021
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03313674
Brief Title
Investigation of Seasonal Variations of Brain Structure and Connectivity in SAD
Official Title
Seasonal Affective Disorder: Exploratory Investigation of Seasonal Variations in Brain Structure and Connectivity as a Predictor for Depressive Severity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
October 5, 2019 (Actual)
Study Completion Date
October 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder, Major Depressive Disorder, Neuroimaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Seasonal Affective Disorder
Arm Type
Experimental
Arm Description
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
Arm Title
Major Depressive Disorder
Arm Type
No Intervention
Arm Description
SAD patients will be compared to unipolar depressed patient cohort, who will be imaged in the winter and the summer.
Arm Title
Healthy Controls
Arm Type
No Intervention
Arm Description
SAD patients will be compared to healthy controls, who will be imaged in the winter and the summer.
Intervention Type
Device
Intervention Name(s)
Bright Light Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in neural function
Description
Functional MRI Scan
Time Frame
12 months
Title
Changes in connectivity
Description
Diffusion Tensor Imaging Scan
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Executive Function
Description
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
Title
Concentration
Description
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
Title
Memory
Description
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
Title
Blood Serum Metabolomic seasonal variation
Description
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
Title
Depressive severity measured through the • Structured Interview Guide for the Hamilton Depression Rating Scale-SAD version
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for SAD Cohort Male or female between the ages of 18 to 65 years, inclusive Patients who are able and willing to give consent and able to attend study visits Agreement to use light therapy for four weeks 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 Current alcohol and/or substance use disorder Use of cigarettes Past or present psychiatric disorders (axis I and II) other than SAD Taken medications approved and/or employed off-label for depression Previous use of light therapy Use of photosensitive medications Montreal Cognitive Assessment score < 24 Patients with standard contraindications for MR imaging. For example, non-MRI compatible metallic implants including cardiac pacemaker, size limitations etc. Known intolerance or allergies to MRI contrast agent (Gadolinium or Magnevist) including advanced kidney disease Severely impaired renal function (estimated glomerular filtration rate <30ml/min/1.73m2) Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment Pregnant and/or breastfeeding Travelled to another a more southern latitude within 6 months of scan Night shift workers Are participating or have participated in clinical trial or research study in the last 30 days Unable to communicate with investigator and/or staff Diagnosis of a reading disability, dyslexia or significant learning disorder Inclusion Criteria for Unipolar Depression Cohort contraindications Male or female between the ages of 18 to 65 years, inclusive Patients who are able and willing to give consent and able to attend study visits DSM-V diagnosis of major depressive disorder, with a Hamilton Depression Rating Scale score ≥ 22 at screening Exclusion Criteria for Unipolar Depression Cohort Current alcohol and/or substance use disorder Past or present psychiatric disorders (axis I and II) other than SAD Montreal Cognitive Assessment score < 24 Patients with standard contraindications for MR imaging. For example, non-MRI compatible metallic implants including cardiac pacemaker, size limitations etc. Known intolerance or allergies to MRI contrast agent (Gadolinium or Magnevist) including advanced kidney disease Severely impaired renal function (estimated glomerular filtration rate <30ml/min/1.73m2) Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment Pregnant and/or breastfeeding Are participating or have participated in clinical trial or research study in the last 30 days Unable to communicate with investigator and/or staff Diagnosis of a reading disability, dyslexia or significant learning disorder Inclusion Criteria for Healthy Controls Male or female between the ages of 18 to 65 years, inclusive Patients who are able and willing to give consent and able to attend study visits No current or past history of mental disorder No unstable medical disorders Exclusion Criteria for Healthy Controls Use of any medication for a general medical disorder and/or condition that, in the opinion of the investigator, may affect neural structure Alcohol or drug-use within 24 hours of MRI Pregnant and/or breastfeeding Montreal Cognitive Assessment score < 24 Patients with standard contraindications for MR imaging. For example, non-MRI compatible metallic implants including cardiac pacemaker, size limitations etc. Known intolerance or allergies to MRI contrast agent (Gadolinium or Magnevist) Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment Are participating or have participated in clinical trial or research study in the last 30 days Unable to communicate with investigator and/or staff
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nir Lipsman, MD PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Investigation of Seasonal Variations of Brain Structure and Connectivity in SAD

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