Seasonal Affective Disorder: Exploratory Investigation of Seasonal Variations in Brain Structure and Connectivity as a Predictor for Depressive Severity
Bright Light Therapy
Trastorno depresivo
+ Trastornos Mentales
+ Trastorno Depresivo Mayor
Estudio Diagnóstico
Resumen
Fecha de inicio: 1 de noviembre de 2017
Fecha en la que se inscribió al primer participante.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).
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 23 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio Diagnóstico
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 65 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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 Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Sunnybrook Health Science Centre
Toronto, CanadaAbrir Sunnybrook Health Science Centre en Google Maps