- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03313674
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Science Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in neural function
Time Frame: 12 months
|
Functional MRI Scan
|
12 months
|
Changes in connectivity
Time Frame: 12 months
|
Diffusion Tensor Imaging Scan
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Executive Function
Time Frame: 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
|
12 months
|
Concentration
Time Frame: 12 months
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Digit Symbol Substitute Test will be used to measure concentration.
Survey score is determined by the number of correct and incorrect responses
|
12 months
|
Memory
Time Frame: 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.
|
12 months
|
Blood Serum Metabolomic seasonal variation
Time Frame: 12 months
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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.
|
12 months
|
Depressive severity measured through the • Structured Interview Guide for the Hamilton Depression Rating Scale-SAD version
Time Frame: 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. |
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nir Lipsman, MD PhD, Sunnybrook Health Sciences Centre
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 281-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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