Seasonal Affective Disorder and Visual Impairment

Visual Impairment Clinical Trial

Official title:

The Neurobiology of Seasonal Affective Disorder: Exploring the High Prevalence in Severe Visual Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403959
• Other study ID #: BlindSAD
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: March 12, 2020

Study information

• Verified date: September 2020
• Source: Psychiatric Centre Rigshospitalet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mood Disorders
• Seasonal Affective Disorder
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Device:
• light therapy
6 weeks morning treatment with bright light therapy in own home.

Locations

Country	Name	City	State
Denmark	Mental Health Center Copenhagen	Copenhagen Ø

Sponsors (2)

Lead Sponsor	Collaborator
Psychiatric Centre Rigshospitalet	Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	feasibility of light therapy	side effects and tolerability of light therapy	6 weeks
Other	Late sustained post-illumination pupillary response to blue light	Difference in late PIPR (10-30 seconds post-illumination) following high intensity blue light between SAD and non-SAD and between seasons	6 months
Primary	treatment response	Reduction in depression severity on the Structured interview guide for the Hamilton Depression Rating Scale - Seasonal affective disorder version (25 items version total score with range 0-78. Results from Hamilton Rating Scale for Depression 17 items (range 0-52) and the 8 item atypical symptom subscale (range 0-26) are reported. Higher scores indicate higher severity.	6 weeks
Primary	saliva melatonin concentration	Differences in melatonin secretion as indicated by area under curve (AUC) between SAD and non-SAD (summer and winter).	6 months
Secondary	PIPR - light therapy	Correlation between treatment response and ipRGC function as measured by the sustained (10-20 seconds) post-illumination pupillary contraction following blue light stimulation	6 weeks