A multi-center, randomized, double-blind, endpoint-blind, placebo parallel control, superiority clinical study to evaluate the efficacy and safety of EFFL therapy lamp in the treatment of mild to moderate depression

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Treament group:Treatment with EFFL Therapy Lamp, illuminance: 10000 lux;Control group:Treated with a placebo lamp, illumination: 900 lux; CONDITION: depressive disorder PRIMARY OUTCOME: Hamilton depression scale‐17; SECONDARY OUTCOME: Pittsburgh sleep quality index;Montgomery‐Asberg depression rating scale;Self‐rating depression scale;Clinical global impressions scale;Treatment emergent symptom scale;Morningness‐eveningness questionnaire;Fatigue severity Scale;Sleep diary;Electrocardiogram;General demographic questionaire;Vital signs; INCLUSION CRITERIA: 1. Meet the diagnostic criteria of mild to moderate depression in ICD‐10; 2. Hamilton Depression Scale HAMD 17‐item score between (inclusive) 17 and 25; 3. Aged 18‐65 years, gender is not limited; 4. Voluntarily participate in this study and sign the informed consent.
Epistemonikos ID: fde74440c68c59dc1bf32d8193ef23cfd4140670
First added on: Feb 20, 2024