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Seasonal Affective Disorder and Visual Impairment

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ClinicalTrials.gov Identifier: NCT03403959
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
Glostrup University Hospital, Copenhagen
Information provided by (Responsible Party):
Helle Østergaard Madsen, Psychiatric Centre Rigshospitalet

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.


Condition or disease Intervention/treatment Phase
Seasonal Affective Disorder Visual Impairment Device: light therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor and the participant is unaware of ipRGC function prior to and during treatment
Primary Purpose: Treatment
Official Title: The Neurobiology of Seasonal Affective Disorder: Exploring the High Prevalence in Severe Visual Impairment
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAD
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
6 weeks morning treatment with bright light therapy in own home.

No Intervention: non-SAD
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.



Primary Outcome Measures :
  1. treatment response [ Time Frame: 6 weeks ]
    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.

  2. saliva melatonin concentration [ Time Frame: 6 months ]
    Differences in melatonin secretion as indicated by area under curve (AUC) between SAD and non-SAD (summer and winter).


Secondary Outcome Measures :
  1. PIPR - light therapy [ Time Frame: 6 weeks ]
    Correlation between treatment response and ipRGC function as measured by the sustained (10-20 seconds) post-illumination pupillary contraction following blue light stimulation


Other Outcome Measures:
  1. feasibility of light therapy [ Time Frame: 6 weeks ]
    side effects and tolerability of light therapy

  2. Late sustained post-illumination pupillary response to blue light [ Time Frame: 6 months ]
    Difference in late PIPR (10-30 seconds post-illumination) following high intensity blue light between SAD and non-SAD and between seasons



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403959


Contacts
Contact: Helle Ø Madsen, MD +45 38647068 helle.oestergaard.madsen@regionh.dk

Locations
Denmark
Mental Health Center Copenhagen Recruiting
Copenhagen Ø, Denmark, 2100
Contact: Helle Ø Madsen, MD    +4538647068    helle.oestergaard.madsen@regionh.dk   
Contact: Klaus Martiny, MDSc    +4538647100    klaus.martiny@regionh.dk   
Sponsors and Collaborators
Psychiatric Centre Rigshospitalet
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Helle Ø Madsen, MD Mental Health Center Copenhagen

Responsible Party: Helle Østergaard Madsen, MD, Psychiatric Centre Rigshospitalet
ClinicalTrials.gov Identifier: NCT03403959     History of Changes
Other Study ID Numbers: BlindSAD
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helle Østergaard Madsen, Psychiatric Centre Rigshospitalet:
pupillometry
light therapy
visual impairment
melatonin
ipRGC

Additional relevant MeSH terms:
Vision, Low
Disease
Mood Disorders
Vision Disorders
Seasonal Affective Disorder
Pathologic Processes
Mental Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Depressive Disorder
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants