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
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|
|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|
|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|
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.
- 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.
- 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).
- 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
- feasibility of light therapy [ Time Frame: 6 weeks ]side effects and tolerability of light therapy
- 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
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
|Contact: Helle Ø Madsen, MD||+45 firstname.lastname@example.org|
|Mental Health Center Copenhagen||Recruiting|
|Copenhagen Ø, Denmark, 2100|
|Contact: Helle Ø Madsen, MD +4538647068 email@example.com|
|Contact: Klaus Martiny, MDSc +4538647100 firstname.lastname@example.org|
|Principal Investigator:||Helle Ø Madsen, MD||Mental Health Center Copenhagen|