Clinical trial NCT03403959: Seasonal Affective Disorder and Visual Impairment
Official title: The Neurobiology of Seasonal Affective Disorder: Exploring the High Prevalence in Severe Visual Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Affective Disorder
Visual Impairment
Keywords: pupillometry
light therapy
visual impairment
melatonin
ipRGC
Lead sponsor: Psychiatric Centre Rigshospitalet
Sponsor class: OTHER
Collaborators: name: Glostrup University Hospital, Copenhagen
First posted: 2018-01-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study combines two models: a case/control study with observational outcomes where all cases are consequently included in a non-randomized interventional study
Primary purpose: TREATMENT

Brief summary: As a subtype of major depressive disorder, seasonal affective disorder (SAD) or winter depression causes severe reductions in both quality of life and productivity and results in high morbidity and frequent sick leave (1). SAD is a prevalent disorder with rates as high as 3-5% in central European countries and 8-10% in Scandinavian countries. In our recent screening survey among persons with severe visual impairment or blindness (visual acuity \< 6/60), we found a strikingly high prevalence of SAD of 17 % compared to 8% in the fully sighted control group. Persons with maintained light perception had a highly increased SAD prevalence of 18 % whereas no light perception (NLP) respondents had an SAD prevalence of 13 %. Light is unquestionably of great importance in the development and treatment of SAD. It is suggested that a reduced retinal sensitivity to light leads to sub-threshold light input to the brain and consequently to the development of SAD. The novel retinal non-visual photoreceptors, the intrinsically photosensitive retinal ganglion cells (ipRGCs), are involved in the regulation of circadian rhythm and mood and their function are in part independent of the function of the classical rod and cone photoreceptors which form the basis of conscious visual perception. Function of the ipRGCs can be assessed by chromatic pupillometry where the sustained pupillary contractions following blue light stimulation (PIPR) is the main outcome. In persons with SAD without eye disorder the function of the ipRGCs is reduced. We here wish to investigate associations between ipRGC function and SAD symptoms, circadian profile and treatment response to light therapy in persons with visual impairment.

Persons with visual impairment (SAD and non-SAD) are assessed for ipRGC function with chromatic pupillometry, for seasonal mood variation by interview and questionnaire and for diurnal melatonin secretion by saliva analysis summer and winter. In winter SAD participants are treated with daily morning bright light for 6 weeks. Reduction in depression scores and tolerability is recorded.


Eligibility criteria: Inclusion Criteria:

Seasonal affective disorder. Visual impairment (Snellen visual acuity \< 6/18) or visual field reduction (MD\<10).

Exclusion Criteria:

Alcohol or drug abuse. Current or planned pregnancy. Other neuropsychiatric disorder. Antidepressant medication. Regular use of melatonin.

Primary outcomes:
measure: treatment response
timeFrame: 6 weeks
measure: saliva melatonin concentration
timeFrame: 6 months
Secondary outcomes:
measure: PIPR - light therapy
timeFrame: 6 weeks
Other outcomes:
measure: feasibility of light therapy
timeFrame: 6 weeks
measure: Late sustained post-illumination pupillary response to blue light
timeFrame: 6 months
Locations:
city: Copenhagen Ø
country: Denmark
facility: Mental Health Center Copenhagen
Study officials:
affiliation: Mental Health Center Copenhagen
name: Helle Ø Madsen, MD
role: PRINCIPAL_INVESTIGATOR
References: