Seasonal Affective DisorderNCT03313674
Investigation of Seasonal Variations of Brain Structure and Connectivity in SAD
A study testing Bright Light Therapy in people with Seasonal Affective Disorder and Major Depressive Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Affective Disorder, Major Depressive Disorder, Neuroimaging
- What is being tested?
- Bright Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2017to 5 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 41Show fewer
- 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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seasonal Affective Disorder: Exploratory Investigation of Seasonal Variations in Brain Structure and Connectivity as a Predictor for Depressive Severity
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).
- Being tested
- Bright Light Therapy
- Medical subject headings
- Seasonal Affective Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Light TherapyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neural function
Functional MRI Scan
Measured: 12 months
Changes in connectivity
Diffusion Tensor Imaging Scan
Measured: 12 months
Secondary outcomes (5)
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
Measured: 12 months
Concentration
Digit Symbol Substitute Test will be used to measure concentration. Survey score is determined by the number of correct and incorrect responses
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start1 Nov 2017
- Primary completion5 Oct 2019
- Study completion5 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Affective DisorderStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nir Lipsman, Sunnybrook Health Sciences Centre
- Investigators
- Nir Lipsman, MD PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313674
- Sponsor's protocol ID
- 281-2017
- Status last verified
- Mar 2021
- First submitted
- 10 Oct 2017
- Last updated
- 16 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seasonal Affective Disorder: Exploratory Investigation of Seasonal Variations in Brain Structure and Connectivity as a Predictor for Depressive Severity
- ClinicalTrials.gov ID
- NCT03313674
- Acronym / sponsor ID
- 281-2017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 5 Oct 2019 (actual)
- Study completion
- 5 Oct 2019 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Seasonal Affective Disorder | Experimental | Device: Bright Light TherapyThe 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 |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Male or female between the ages of 18 to 65 years, inclusive
Key exclusion criteria (41 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Light TherapyLight 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 | Device | Seasonal Affective Disorder |
Primary outcome
Changes in neural function
Time frame: 12 months
Functional MRI Scan
Changes in connectivity
Time frame: 12 months
Diffusion Tensor Imaging Scan
5 secondary outcomes
Executive Function
Time frame: 12 months
Concentration
Time frame: 12 months
Memory
Time frame: 12 months
Blood Serum Metabolomic seasonal variation
Time frame: 12 months
Depressive severity measured through the • Structured Interview Guide for the Hamilton Depression Rating Scale-SAD version
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Seasonal Affective Disorder
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Cohort of Patients Suffering From Major Depressive Episode With Evaluation of Sleep, Circadian Rhythms and Psychiatric Disorders
Major Depressive Episode
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Virtual Reality Digital Therapeutics for Seasonal Affective Disorder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nir Lipsman, MD PhD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Light Therapy in people with Seasonal Affective Disorder and Major Depressive Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in neural function (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.