Status:
COMPLETED
Investigation of Seasonal Variations of Brain Structure and Connectivity in SAD
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Seasonal Affective Disorder
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
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 depre...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03313674
Start Date
November 1 2017
End Date
October 5 2019
Last Update
March 16 2021
Active Locations (1)
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1
Sunnybrook Health Science Centre
Toronto, Ontario, Canada, M4N 3M5