Seasonal Affective Disorder and Visual Impairment

NCT03403959 | Completed

• 1 other identifier: BlindSAD
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Affective Disorder; Visual Impairment

Keywords

pupillometry; light therapy; visual impairment; melatonin; ipRGC

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• PIPR - light therapy

  6 weeks

Other Outcomes (2)

• feasibility of light therapy

  6 weeks

• Late sustained post-illumination pupillary response to blue light

  6 months

Study Arms (2)

SAD

EXPERIMENTAL

Persons with visual impairment and SAD are assessed by clinical interview, depression rating, diurnal saliva melatonin and cortisol and chromatic pupillometry during symptomatic winter phase and asymptomatic summer phase. Winter assessment is followed by a 6 week light therapy protocol ending with assessment of depression severity and repeated pupillometry.

Device: light therapy

non-SAD

NO INTERVENTION

Control participants with similar visual impairment but without SAD/sSAD are assessed by clinical interview, depression rating, diurnal saliva melatonin and cortisol and chromatic pupillometry in winter and summer.

Interventions

light therapy DEVICE

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

SAD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Psychiatric Centre Rigshospitalet: lead
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (1)

Mental Health Center Copenhagen

Copenhagen Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Seasonal Affective Disorder; Vision Disorders

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Helle Ø Madsen, MD

  Mental Health Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor and the participant is unaware of ipRGC function prior to and during treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: The study combines two models: a case/control study with observational outcomes where all cases are consequently included in a non-randomized interventional study

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 19, 2018
• Study Start: December 1, 2017
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)