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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068298
Enrollment
Unknown
Registered
2023-02-14
Start date
2023-02-23
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depressive disorder

Interventions

Treament group:Treatment with EFFL Therapy Lamp, illuminance: 10000 lux
Control group:Treated with a placebo lamp, illumination: 900 lux

Sponsors

Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Organic brain lesions (such as cerebral hemorrhage, massive cerebral infarction, encephalitis, epilepsy); Cardiac QTc interval > 450ms; 2. Patients who are at serious risk of suicide or have attempted suicide; 3. Patients who are receiving other psychotherapy; 4. Pregnant, breastfeeding or planning pregnancy during the trial period; 5. Drug abusers; 6. Patients suffering from other unstable medical diseases; 7. Patients with retinopathy of any degree (including retinal diseases due to diabetes); 8. Those who have taken citalopram or received phototherapy within 30 days before the initial diagnosis; 9. Seriously ill patients, including those with heart, liver, kidney, respiratory, endocrine, nerve, blood and other diseases and not yet stable, and those with a history of convulsions; 10. Severe allergy and multiple adverse drug reactions; 11. Patients who regularly or currently take psychotropic drugs, including lithium, melatonin, and tryptophan; 12. Patients who have previously taken ß-blockers; 13. Patients with hypertension who are taking guanethidine, Reserpine, clonidine, or methyldopa (these medications may alter mood); 14. Patients who have taken any antidepressant drugs, such as monoamine oxidase inhibitors and heterocyclic antidepressants, within 30 days before their initial diagnosis;

Design outcomes

Primary

MeasureTime frame
Hamilton depression scale-17;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactBin Zhang

Nanfang Hospital, Southern Medical University

zhang73bin@hotmail.com+86 13527807502

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026