depression
Conditions
Interventions
Test group:Depression Auxiliary Intervention Treatment Software Treatment
Control group:Depression assisted intervention treatment software (consolation control software) treatment
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in the experiment and sign the consent of informedness; 2. Age 18-60 years (including 18 and 60 years old), gender is not limited; 3. During the screening, the clinical diagnosis is in line with the "Diagnostic and Statistics of Mental Disorders, 5th Edition, DSM-5) diagnostic disorders (MDD) diagnostic standards (through international neuropathy" Simplified interview questionnaires (MINI-International NeuropSychiatric Interview (M.I.N.I.7.0.2) confirmed diagnosis, diagnosed as severe depression disorders (currently), patients with a single attack or repeated attack and are not accompanied by psychiatric symptoms; 4. Patients with a MADRS (MADRS) score at the time of screening is greater than equal to 18 points and less than 30 points; 5. The treatment of antidepressant drugs within 2 weeks before the screening (at least 6 weeks), and patients who can maintain the treatment of antidepressant drugs during the test during the trial; 6. Cultural level above elementary school, understand the content of the table, and be proficient in using smartphones.
Exclusion criteria
Exclusion criteria: 1. Clinical diagnostic patients who comply with severe depression disorders (MDD) in DSM-5 are other patients with severe depression disorders (MDD) diagnostic standards for mental disorders (confirmed by M.I.N.I.7.0.2); 2. Patients with refractory depression (antidepressants with two or more chemical structures with different chemical structures in the past, patients with full amount and sufficient treatment (for at least 4 weeks according to the maximum dose of instructions); 3. Patients with alcohol and drug dependencies in the past; 4. Female patients during pregnancy or lactation, or men or women patients with fertility plans during clinical trials; 5. At present, there are severe physical diseases, and thyroid diseases (thyroid hormone (TSH) exceeds the upper limit of normal values ??during screening), or researchers believe that patients with hypothyroidism or hyperthyroidism (judged by researchers, allowing the laboratory that meets the exclusion standards The results of the inspection were reviewed, but the review must be completed within the screening period); 6. There are obvious suicide attempts or behaviors, the "10. suicide concept" score in the MADRS score is greater than 4 points; 7. Patients received other antidepressant treatment methods within 3 months before their selection, including Chinese medicine, improved electric shock therapy, menstrual magnetic stimulation, biological feedback therapy, phototherapy, acupuncture and other physical therapy and system psychotherapy; 8. Patients who are unwilling to participate in psychotherapy or consider psychotherapy invalid; 9. Patients who have participated in or participated in drug clinical trials or are participating in drugs within 3 months, or patients who have participated in or participating in other equipment clinical trials within one month before the screening; 10. Researchers are not suitable for other situations that are not suitable for entering the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 8 weeks of treatment, the improved value of the MADRS score compared to the baseline;Instrument performance evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in MADRS score from baseline at 4 weeks of treatment (28 +7 days of treatment);Treatment was effective for 8 weeks (56 days +7 days);Response rate after 8 weeks of treatment (56 days +7 days of treatment);Suicidal ideation scores improved from baseline after 4 weeks of treatment (28+7 days) and 8 weeks of treatment (56 +7 days);Improvement from baseline on the Hamilton Anxiety Scale (HAMA) score after 4 weeks of treatment (28+7 days) and 8 weeks of treatment (56 +7 days);Clinical Global Impression (CGI) score improvement from baseline at 4 weeks (28+7 days of treatment) and 8 weeks (56 +7 days of treatment);Improvement in Sheehan Disability Scale (SDS) scores from baseline after 4 weeks of treatment (28+7 days) and 8 weeks of treatment (56 +7 days);Improvement in Self-Assessment of Cognitive Impairment Questionnaire (PDQ-D) scores from baseline after 4 weeks of treatment (28+7 days) and 8 weeks of treatment (56 +7 days); | — |
Countries
China
Contacts
Public ContactLingjiang Li
The Second Xiangya Hospital, Central South University
Outcome results
None listed