Investigation of Seasonal Variations of Brain Structure and Connectivity in SAD

NCT03313674 | Completed

• 1 other identifier: 281-2017
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Changes in neural function

  Functional MRI Scan

  12 months

• Changes in connectivity

  Diffusion Tensor Imaging Scan

  12 months

Secondary Outcomes (5)

• Executive Function

  12 months

• Concentration

  12 months

• Memory

  12 months

• Blood Serum Metabolomic seasonal variation

  12 months

• Depressive severity measured through the • Structured Interview Guide for the Hamilton Depression Rating Scale-SAD version

  12 months

Study Arms (3)

Seasonal Affective Disorder

EXPERIMENTAL

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

Device: Bright Light Therapy

Major Depressive Disorder

NO INTERVENTION

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

Healthy Controls

NO INTERVENTION

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

Interventions

Bright Light Therapy 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

Seasonal Affective Disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Seasonal Affective Disorder; Depressive Disorder, Major

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Nir Lipsman, MD PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon, Scientist

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 18, 2017
• Study Start: November 1, 2017
• Primary Completion: October 5, 2019
• Study Completion: October 5, 2019
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)