Investigation of Seasonal Variations of Brain Structure and Connectivity in SAD

NCT ID: NCT03313674

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2019-10-05

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).

Conditions

Seasonal Affective Disorder; Major Depressive Disorder; Neuroimaging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Bright Light Therapy

Intervention Type: DEVICE

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

Major Depressive Disorder

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy Controls

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bright 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

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

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

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Nir Lipsman

Neurosurgeon, Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nir Lipsman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

281-2017

Identifier Type: -

Identifier Source: org_study_id