Major depressive disorder
Conditions
Interventions
No group:Agomelatine monotherapy
Sponsors
Beijing Anding Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 65, gender unlimited; 2. Meet the DSM-?-TR diagnostic criteria for depression, no psychotic symptoms, single or repeated episodes (296.2/296.3); 3. The total score of 17 items of HAMD scale at screening and baseline was =17; 4. The subject signs the informed consent.
Exclusion criteria
Exclusion criteria: 1. Current or past diagnosis of axis I in line with DSM-IV-TR except for depression; 2. Has a serious or unstable physical disease, epilepsy, or any other medical condition that would prevent the patient from participating in the study/interfere with the evaluation of the study; 3. HIV antibody positive, or hepatitis B virus carrier/patient, hepatitis C virus carrier/patient; ALT and AST were higher than the upper limit. Cr higher than the upper limit of normal), patients with cirrhosis or active liver disease; 4. Abnormal laboratory tests are judged to be clinically significant, and the researchers believe that they affect the efficacy of the test drug or the safety of the subjects; 5. Binge drinking within 30 days prior to screening or alcohol or drug dependence within 6 months prior to screening; 6. Patients who failed to receive standard treatment with agomelatine in the past, or failed to receive adequate treatment with two or more antidepressants in sufficient quantity and course of treatment in this attack; 7. The duration of this depressive episode is more than 2 years; 8. For those with apparent suicide attempt or behavior, HAMD Article 3 (suicide) score =3; 9. Allergy, or known allergy or intolerance to agomelatine or its excipients (refer to the instructions); 10. Breastfeeding or pregnant women or those (including men) who want to have children during the trial, as well as men and women who do not have access to safe and effective contraceptive measures; 11. Those who are taking CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, propranolol, gepfloxacin, enoxacin, etc.); 12. Patients who are using antipsychotics, antidepressants, and mood stabilizers and have less than 5 half-lives before baseline cleansing; 13. Patients who received electroconvulsive therapy (ECT), systematic psychotherapy (interpersonal therapy, psychoanalysis, cognitive behavioral therapy), and transcranial magnetic stimulation within 3 months prior to screening; Those who had received light therapy within 2 weeks before screening; 14. Patients who had used monoamine oxidase inhibitors within 2 weeks before screening, and patients who had used fluoxetine within 1 month before screening; 15. Those who are receiving acupuncture or traditional Chinese medicine treatment; 16. Participants in any clinical trial within 30 days prior to screening; 17. The investigator determined that there were conditions that made it inappropriate to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total HAMD-17 scores from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMD, QIDS-SR, CGI, SDS, Q-LES-Q-SF, AIS, ASEX changes from baseline; | — |
Countries
China
Contacts
Public ContactLuo Jiong
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed