depression
Conditions
Interventions
Test group:Patients with mild depression treated with the depressive symptoms psychotherapy and rehabilitation training software
Patients with moderate to severe depression treated with the depressive symptoms psychotherapy and rehabilitation training software combined with Fluoxetine Hydrochloride Tablets.
Control group:Patients with mild depression are treated with health education placebo software
Patients with moderate to severe depression are treated with health education placebo software combined with Fluoxetine Hydrochloride Tablets.
Sponsors
Peking University Sixth Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Ages 8 to 17 (including 8 and 17); gender is not restricted; 2. At the time of screening, the clinical diagnosis meets the criteria for Major Depressive Disorder (MDD) in the *Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)*, DSM-5), confirmed via the School-Aged Children’s Schedule for Affective Disorders and Schizophrenia—Present and Lifetime (K-SADS-PL) as having Major Depressive Disorder (current), with either a single episode or recurrent episodes and no psychotic symptoms; 3. Patients with a score greater than 30 on the Children’s Depression Rating Scale – Revised (CDRS-R) at screening; 4. Patients who are proficient in using a smartphone; 5. Participants and their guardians voluntarily agree to participate and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients currently suffering from mental disorders other than depressive disorders; 2. Patients who have previously received an adequate course of treatment with a single antidepressant at an adequate dose but have not responded; 3. Patients with significant suicidal ideation or behavior, with a score greater than 4 on item 13 ("Suicidal Ideation") of the CDRS-R; 4. Patients with severe, unstable systemic diseases such as cardiovascular, hepatic, renal, hematological, endocrine disorders, or malignant tumors; Patients with ophthalmic conditions preventing prolonged use of electronic screens; patients with thyroid disease (where thyroid-stimulating hormone [TSH] exceeds the upper limit of normal at screening), or patients whom the investigator believes have hypothyroidism or hyperthyroidism (at the investigator’s discretion, laboratory test results meeting exclusion criteria may be rechecked once, provided the recheck is completed within the screening period); 5. History of epileptic seizures (excluding convulsions caused by febrile seizures in children); 6. Patients with intellectual disabilities, speech comprehension or expression impairments, visual or hearing impairments, or motor impairments that prevent cooperation with treatment; 7. Patients who have received other antidepressant herbal treatments or non-pharmacological therapies (including modified electroconvulsive therapy, transcranial magnetic stimulation, biofeedback therapy, light therapy, acupuncture, and other physical therapies, as well as systematic psychotherapy) within 3 months prior to screening; 8. Patients who explicitly refuse to participate in psychotherapy or believe psychotherapy to be ineffective; 9. Patients with a positive pregnancy test; 10. Patients who have received systematic antidepressant medication prior to screening and have not discontinued fluoxetine for at least 4 weeks, or other antidepressants for at least 2 weeks; 11. Patients who have participated in or are currently participating in other drug or device clinical trials within the past three months; 12. Other circumstances deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in Children's Depression Rating Scale-Revised (CDRS-R) score from baseline to Week 8 of treatment.;Device Performance Evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in CDRS-R score from baseline at Week 1, Week 2, Week 3, Week 4 and Week 6 of treatment.;Treatment response rate at Week 1, Week 2, Week 3, Week 4, Week 6 and Week 8 of treatment.;Remission rate at Week 1, Week 2, Week 3, Week 4, Week 6 and Week 8 of treatment.;Clinical Global Impression (CGI) scores at Week 2, Week 4 and Week 8 of treatment.;The change in Children's Depression Inventory (CDI) score from screening baseline at Week 2, Week 4 and Week 8 of treatment.;The change in Conners' Parent Symptom Questionnaire (PSQ) score from screening baseline at Week 2, Week 4 and Week 8 of treatment.; | — |
Countries
China
Contacts
Public ContactJing Liu
Peking University Sixth Hospital
Outcome results
None listed