Terminé

Seasonal Affective Disorder: Exploratory Investigation of Seasonal Variations in Brain Structure and Connectivity as a Predictor for Depressive Severity

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Ce qui est testé

Bright Light Therapy

Dispositif médical
Qui peut participer

Troubles Mentaux+2

+ Trouble dépressif majeur

+ Trouble Dépressif

De 18 à 65 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude diagnostique

Interventionnel
Date de début : novembre 2017
Voir le détail du protocole

Résumé

Sponsor principalSunnybrook Health Sciences Centre
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 novembre 2017

Date à laquelle le premier participant a commencé l'étude.

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).

Titre officielSeasonal Affective Disorder: Exploratory Investigation of Seasonal Variations in Brain Structure and Connectivity as a Predictor for Depressive Severity
NCT03313674
Sponsor principalSunnybrook Health Sciences Centre
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

23 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Diagnostic

Cette étude évalue de nouvelles méthodes pour diagnostiquer ou identifier une maladie, afin de la détecter plus facilement et plus tôt.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 65 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Troubles MentauxTrouble dépressif majeurTrouble DépressifTrouble affectif saisonnierTroubles de l'humeur

Critères

Inclusion Criteria for SAD Cohort 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 Exclusion Criteria for SAD Cohort 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 Inclusion Criteria for Unipolar Depression Cohort contraindications 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 Exclusion Criteria for Unipolar Depression Cohort 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 Inclusion Criteria for Healthy Controls 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 for Healthy Controls 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

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

Un seul groupe d'intervention est désigné dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
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

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

Sunnybrook Health Science Centre

Toronto, CanadaOuvrir Sunnybrook Health Science Centre dans Google Maps
Terminé1 Centres d'Étude