Status:
NOT_YET_RECRUITING
The Efficacy and Feasibility of Bright Light Therapy in Adolescents With Depressive Disorder
Lead Sponsor:
Peking University Sixth Hospital
Collaborating Sponsors:
Beijing HuiLongGuan Hospital
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
13-17 years
Phase:
NA
Brief Summary
Major Depressive Disorder (MDD) is a chronic disease characterized by a high prevalence, low cure rate, and significant disability. Globally, depression is recognized as the leading cause of illness a...
Eligibility Criteria
Inclusion
- Adolescents with Major Depressive Disorder
- all of the following conditions were met for inclusion:
- Meet the diagnostic criteria for depressive episodes in the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) (either first or recurrent), and be clearly diagnosed by two physicians using MINI-kid 2.0;
- Age 13 to 17 years, right-handed, and gender-neutral; ③Not currently on medication; or have been stabilized on the original medication regimen for at least 1 week; ④ Hamilton Depression Scale (HAMD-17) score ≥14 at baseline; ⑤ Years of education ≥ 5 years and can cooperate in completing the scale assessment;
- Subjects volunteered to participate in the study, and both subjects and guardians signed an informed consent form.
Exclusion
- excluded if any of the following conditions are met:
- A history of previous or current episodes of other psychiatric disorders, such as (schizophrenia, autism spectrum disorders, and schizoaffective disorders, etc.);
- Previous history of drug or substance abuse or dependence;
- Total score of ≥ 8 on the Young's Mania Scale as assessed by the investigator for the subject;
- ④ Have received, or are currently receiving, or have planned to receive in the last month, other systemic interventions other than medication in the 6 months prior to enrollment, e.g., systemic psychotherapy (1 to 2 times per month for more than 6 months), physical therapy other than phototherapy, or exercise therapy;
- ⑤ Those who are medically unstable, or unable to cooperate in completing the study; those who are currently at serious risk of suicide as assessed by the investigator (HAMD-17 entry 3 score ≥ 3);
- Comorbid serious physical illnesses such as severe liver function abnormalities, hyper/hypothyroidism and abnormal thyroid function, encephalitis, head trauma or coma, epilepsy, loss of consciousness, diabetes mellitus, renal failure, etc.; or those whose clinical laboratory findings at the time of enrollment are, in the opinion of the investigator, significantly out of the reference range and of clinical significance; ⑦ Comorbid visual pathway diseases (retinal detachment, optic nerve atrophy, macular degeneration, etc.), systemic diseases that have an impact on the retina, high myopia (myopia of 600 degrees and above); or those who are using photosensitizers, drugs with potential photosensitizing effects (e.g., chlorpromazine, tricyclic antidepressant, chrysothema, etc.); ⑧ According to the opinion of the research group, those who are not suitable for other conditions of this study.
- Adolescent Health Controls
- Criteria for inclusion: All of the following conditions were met for inclusion:
- Age 13-17 years old, right-handed, gender is not limited;
- Years of education ≥ 5 years, can cooperate with the completion of the scale assessment; ③Subjects volunteered to participate in the study, and both subjects and guardians signed an informed consent form.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06913309
Start Date
April 1 2025
End Date
December 31 2027
Last Update
April 6 2025
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