depressive disorder
Conditions
Interventions
TJ0113:200mg QD, 28 Days
Placebo Group:200mg QD, 28 Days
Sponsors
Zhejiang Xiaoshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in clinical trials, sign informed consent forms, understand and follow the protocol, fully understand the content, process and possible adverse reactions of the trials, and indicate the date of signing; 2. Are between the ages of 18 and 65 years, inclusive; 3. Meet the diagnostic criteria of DSM-5 (American Handbook of Diagnosis and Statistics of Mental Disorders (Fifth Edition)) for moderate and severe depression without psychotic symptoms; 4. Patients with moderate or severe depression had not used antidepressants, antianxiety drugs, antipsychotics, mood stabilizers, benzodiazepines sedative hypnotics, etc., or had stopped using psychotropic drugs for at least 14 days (fluoxetine for at least 21 days) before enrollment; 5. The score of Hamilton Depression Scale (HAMD-17) =18 points in screening period and baseline period; 6. Agree to stop using other antidepressants, antianxiety drugs, antipsychotics, mood stabilizers, benzodiazepines sedative and hypnotic drugs during the study treatment; 7. Subject and his/her partner has no plans to have children, no plans to donate sperm or eggs, and voluntarily use effective contraceptive methods (such as abstinence, condoms, etc.) during the screening period until 6 months after the end of the trial; Male subjects should agree to refrain from donating sperm from the start of dosing until 6 months after stopping study treatment, and female subjects should agree to refrain from donating eggs from the start of dosing until 6 months after stopping study treatment.
Exclusion criteria
Exclusion criteria: 1. Patients with serious or unstable cardiovascular diseases, liver diseases, kidney diseases, blood diseases, endocrine diseases and other physical diseases or medical history are judged by the investigator to be clinically abnormal in physical examination, vital signs, 12-lead electrocardiogram (ECG), laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, etc.) and are not suitable for inclusion; 2. A history of any disorder other than DSM-5 depression with psychiatric symptoms, including but not limited to bipolar and related disorders, compulsive and related disorders, trauma and stress-related disorders, schizophrenia, anxiety disorders, sleep-wake disorders, substance-related or addictive disorders, and depression secondary to other mental or physical disorders; 3. The score of HAMD-17 in baseline period is less than or equal to 25% compared with that in screening; 4. The subject has committed suicide within one year before the first drug administration, or the score of item 3 (suicide item) of HAM-D17 scale at screening or baseline is =3, and there is a risk of suicide, or the subject has a history of suicidal intention/self-mutilation in the current period of depression; 5. Have a history of severe allergies; 6. A history of alcohol or drug dependence/substance abuse (including benzodiazepines, other than nicotine or caffeine) in the last year; 7. Those who were receiving systematic psychotherapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy, etc.), music therapy, exercise therapy, acupuncture, etc., at the time of screening and/or at baseline, and still needed to receive the above therapy during the study; 8. Subjects received electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), light therapy, etc., within 3 months before screening, or the investigators judged that the subjects need to receive such treatment at present; 9. Screening or baseline visiting women who are positive in pregnancy test, are pregnant, breast-feeding or plan to get pregnant during the test; 10. Infectious disease screening results are positive; 11.Unable to swallow oral drugs, or judged by the investigator, there is any surgical situation or illness that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or any surgical situation or illness that may cause harm to the subjects participating in the experiment; 12. Those who have participated in other drug clinical trials within 3 months prior to screening; 13. The investigator evaluates that the subjects have other factors that may affect the compliance, or the subjects are unable to participate in the experiment due to their own reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The score of Hamilton Depression Scale (HAMD-17) changed from baseline after 4 weeks of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of HAMD-17 score compared with baseline (1, 2, 3 weeks, 1 week after drug withdrawal);;2. Changes of Montgomery-Asperger Depression score compared with baseline( 1, 2, 3, 4 weeks of treatment and 1 week of drug withdrawal.);3. Changes of the score of CGI-S compared with the baseline(2,4 weeks of treatment and one week after drug withdrawal);;4. The change of the score of CGI-I after 2, 4 weeks of treatment and 1 week of drug withdrawal;;5. Remission rate: the percentage of subjects with HAMD-17 score =7 after 4 weeks of treatment;;6. Effective rate: the percentage of subjects whose HAMD-17 score decreased by more than 50% after 4 weeks of treatment.; | — |
Countries
China
Contacts
Public ContactJian Chen/Jianlong Huang
Zhejiang Xiaoshan Hospital
Outcome results
None listed