ight Therapy for better Mood and Metabolic control: a randomised double-blind placebo-controlled clinical trial in patients with Type 2 Diabetes Mellitus and Depressio

Completed

• Conditions: adult onset diabetes; Depression; Type 2 Diabetes Mellitus; 10018424; 10027946

• Registration Number: NL-OMON44883
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 98

Inclusion Criteria

Healthy subjects (pilot studie):
(1) Age 18-75 years
(2) Physically and psychiatrically healthy, as judged by an expert panel;Patients:
(1) Age 18 years or older
(2) Type 2 Diabetes Mellitus, as judged by an expert panel
(3) Depression (DSM-IV)

Exclusion Criteria

Healthy subjects (pilot studie):
(1) A recent history of a serious medical event, as judged by an expert panel
(2) Hypersensitivity to drugs used
(3) Pregnancy
(4) Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding the purpose, instruction and hence participation in the study
(5) Individuals who are investigator site personnel directly affiliated with the study, or are immediate family;Patients:
(1) Recent history (<2 months ago) of, or current light therapy
(2) Type 1 Diabetes Mellitus
(3) Recent history of a serious medical event or a serious medical condition, as judged by an expert panel
(4) Current use of oral glucocorticoids, melatonin, or cytostatics
(5) Recent change in antidepressant (<1 months ago) or blood-glucose lowering (<1 months ago) medication
(6) Psychosis, mania, (probable) dementia, severe drug or alcohol abuse, delirium, and severe acute suicidality, as judged by an expert panel
(7) Visual Acuity <60%, severe non-proliferative or preproliferative retinopathy, photocoagulated retinopathy, proliferative retinopathy (EURODIAB grades 3,4, and 5), recent history (<6 months ago) of relevant eye surgery, relevant eye surgery scheduled in the near future, senile macula degeneration
(8) A history of light-induced migraine or epilepsy, or severe side effects to light therapy in the past
(9) Hypersensitivity to drugs used
(10) Pregnancy
(11) Shift workers
(12) Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding the purpose, instruction and hence participation in the study
(13) Individuals who have previously completed or withdrawn from the experimental phase of this study
(14) Individuals who are investigator site personnel directly affiliated with the study, or are immediate family

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>o Mean change in IDS-SR scores in the active versus placebo condition (T0-T4).</p><br>