| Eligibility |
Inclusion Criteria:
1. Patients voluntarily participate in the trial and sign the informed consent;
2. Age 18-60 years old (including 18 years old and 60 years old), gender is not limited;
3. The clinical diagnosis complies with the diagnostic criteria for depression in the
"Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, DSM-5" (through
the International Neuropsychiatry Brief Interview Questionnaire (Mini- International
Neuropsychiatric Interview, M.I.N.I.) confirming the diagnosis) without psychotic
symptoms;
4. Patients with Montgomery Depression Rating Scale (MADRS) score greater than or equal
to 12 and less than 30 at screening;
5. Patients who have not received antidepressant systemic treatment within 2 weeks before
screening, and who can maintain no need for antidepressant treatment during the trial
period as assessed by the research doctor; or take serotonin reuptake stably for at
least 6 weeks before screening Inhibitor (Selective Serotonin Reuptake Inhibitor,
SSRI) class, or serotonin and norepinephrine reuptake dual inhibitor
(Serotonin-Norepinephrine Reuptake Inhibitor, SNRI) class, or noradrenergic and
specific serotonergic Antidepressants (Noradrenergic and Specific Serotonergic
Antidepressants, NaSSA) antidepressants, and the medication compliance is 80%-120% and
the drug dose adjustment is less than 20%, and the antidepressant treatment can be
maintained during the trial period as assessed by the clinician patients on the
original treatment regimen;
6. Patients with primary school education or above, who can understand the content of the
scale and can use smart phones proficiently.
Exclusion Criteria:
1. Patients whose clinical diagnosis meets the diagnostic criteria for other mental
disorders except depression in DSM-5 (diagnosis confirmed by M.I.N.I.);
2. Patients with refractory depression (those who have been treated with 2 or more
antidepressants with different chemical structures in the past or currently, and who
have been treated with a sufficient dose and a full course of treatment (at least 4
weeks according to the maximum dose in the instructions) are ineffective);
3. Patients with a history of alcohol and drug dependence;
4. Pregnant or breastfeeding female patients, or male or female patients with
reproductive plans during clinical trials;
5. Those with 10. Suicidal ideation score of MADRS score greater than or equal to 4
points, that is, those with severe suicidal ideation or suicide attempt;
6. Patients received other antidepressant treatment methods within 3 months before
enrollment, including traditional Chinese medicine, modified electroconvulsive therapy
(MECT), transcranial magnetic stimulation, biofeedback therapy, phototherapy,
acupuncture and other physical therapy and system psychology treat;
7. Severe physical disease, severe liver, renal insufficiency and thyroid disease
(Alanine Aminotransferase (ALT), or Aspartate Aminotransferase (AST) exceeds the upper
limit of normal twice at screening, or total Bilirubin (Total Bilirubin, TBIL) exceeds
1.5 times the upper limit of normal; Creatinine (CR) exceeds 1.2 times the upper limit
of normal; Thyroid Stimulating Hormone (TSH) exceeds the upper limit of normal), or as
judged by the investigator Patients with other diseases who are not suitable for
inclusion in this trial; upon the judgment of the investigator, a re-examination of
non-compliant laboratory tests is allowed, but the re-examination must be completed
within the screening period;
8. Patients who clearly express their unwillingness to participate in psychotherapy, or
who think that psychotherapy is ineffective;
9. Patients who have participated in or are participating in drug clinical trials within
3 months before screening, or patients who have participated in or are participating
in other device clinical trials within 1 month before screening;
10. Other conditions judged by the investigator to be unsuitable for inclusion.
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