Depression
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients voluntarily participate in the trial and provide written informed consent. 2.Aged 16 to 40 years (inclusive), any gender. 3.Meet the DSM-5 diagnostic criteria for Major Depressive Disorder (MDD), confirmed by the M.I.N.I. 7.0.2 interview; experiencing a single or recurrent episode of mild to moderate severity without psychotic features. 4.A Montgomery-Åsberg Depression Rating Scale (MADRS) total score of =15 at the screening visit. 5.Free of antidepressant medication for at least 2 weeks prior to screening (at least 6 weeks for fluoxetine), and assessed by the study investigator as likely to remain off antidepressant therapy for the duration of the trial. 6.Have attained at least a junior high school level of education, demonstrate the ability to comprehend the rating scale content, and are proficient in using a smartphone.
Exclusion criteria
Exclusion criteria: 1.Concurrent neurological disorders, cardiovascular diseases, organic brain diseases, history of significant head trauma, epilepsy, or other serious systemic medical conditions. 2.Presence of suicidal or self-harming behavior, or a score of >=3 on Item 10 (Suicidal Thoughts) of the Montgomery-Åsberg Depression Rating Scale (MADRS). 3.Other major psychiatric disorders, such as intellectual disability, pervasive developmental disorder, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, conduct disorder, schizophrenia, obsessive-compulsive disorder (OCD), or other neurological and psychiatric conditions. 4.History of alcohol or substance abuse, loss of consciousness, or history of illicit drug use. 5.Participation in an interventional clinical trial within the 3 months prior to screening. 6.Judged by the investigator to be poorly compliant or otherwise unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement score from baseline on the MDRS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction rate of total MADRS score;Actual number of treatment days / Scheduled number of treatment days; | — |
Countries
China
Contacts
The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China