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van CCT (UK)

van CCT (UK)

Light therapy for depression and diabetes

- candidate number21565
- NTR NumberNTR4942
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jan-2015
- Secondary IDsNL45295.029.13 
- Public TitleLight therapy for depression and diabetes
- Scientific TitleLight Therapy for better Mood and Metabolic control: a randomised double-blind placebo-controlled clinical trial in patients with Type 2 Diabetes Mellitus and Depression
- hypothesis
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Major depression
- Inclusion criteria(1) male and female subjects 18 years or older; (2) having type 2 diabetes mellitus as judged by an expert panel based on HbA1c, diabetes medical history, use of glucose-lowering medication, and when deemed necessary additional tests (e.g. antibodies); and (3) having a major depressive episode according to DSM-IV criteria
- Exclusion criteria1) a recent history of, or current, light therapy; (2) shift worker; (3) a recent change in antidepressant or blood-glucose lowering medication or therapy (e.g. psychotherapy); (4) use of oral glucocorticoids, melatonin, or cytostatics; (5) pregnancy; (6) psychosis, mania, (probable) dementia, severe drug or alcohol abuse, delirium, and severe acute suicidality; (7) a history of light-induced migraine or epilepsy, or severe side effects to light therapy in the past; (8) visual acuity <60%, diabetic retinopathy EURODIAB grades 3, 4 or 5 (severe non-proliferative or preproliferative retinopathy, photocoagulated retinopathy, proliferative retinopathy), senile macula degeneration; (9) a(nother) medical condition or recent medical event that potentially compromises the effects or safety of light therapy
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blinding[default]
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2014
- planned closingdate1-okt-2016
- Target number of participants74
- InterventionsThe intervention will consist of light therapy for four weeks 30 minutes every morning at home with bright white-yellowish light or dim green light.
- Primary outcomeDepression symptoms (Inventory of Depressive Symptoms (IDS)); insulin sensitivity (hyperinsulinaemic euglycaemic clamp).
- Secondary outcomePsychometrical secondary outcome measures will include depression remission (IDS score of 13 or less); anxiety symptoms (Beck Anxiety Inventory); diabetes distress (Problem Areas In Diabetes questionnaire); and quality of life (EQ-5D) and disability (Sheehan Disability Scale). Endocrine secondary outcome measures will include HbA1c, fasting plasma glucose, insulin dosage (in insulin dependant participants) as reported in the trial diary, and number of hypoglycaemic events as reported in the trial diary. Mediating factors that reflect circadian rythmicity will include diurnal HPA-axis activity, objective accelerometer measures of sleep duration, and subjective measures of sleep duration and quality (questionnaires). Other potential mediating factors include autonomic nervous system function; body weight, body mass index, and body composition (percentage of fat and lean muscle, waist-hip ratio) as measured by bioelectrical impedance analysis; and physical activity as measured using a wrist worn accelerometer.
- TimepointsMeasures will be normally performed at three time points: just before the start of light therapy, after completion of four weeks of light therapy, and after four weeks follow-up. Several measures will be evaluated continuously during the intervention period.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator VU University Medical Center, Department of Psychiatry and GGZ Buitenamstel
- Funding
(Source(s) of Monetary or Material Support)
European Foundation for the Study of Diabetes (EFSD) Mental Health Grant
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD13-jan-2015 - 23-feb-2015

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