Depressive Disorders
Conditions
Interventions
acute phase:morinda officinalis oligose capsule
consolidation phase:morinda officinalis oligose capsule
maintenance phase:maintenance phase
Sponsors
Peking University Sixth Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet to ICD - 10 diagnostic criteria of depressive episode, outpatients; 2. Aged 18 to 70 years male and female; 3. HAMD17 score at screening stage and baseline was =18 points =28 points; 4. The kidney Yang deficiency syndrome of TCM: Primary symptom=3 items, secondary symptoms=3 items, total score=15 points; 5. Choose 400 patients whose HAMD17=9, CGI-S=2(last for 2 weeks) at the end of acute phase(last for 8 weeks)into consolidation phase; 6. Choose 120 patients whose HAMD17=9, CGI-S=2(last for 2 weeks) at the end of consolidation phase(last for 24 weeks)into maintenance phase; 7. Patients signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. There was a suicide history in the past, or with a high risk of suicide or suicide tendency at present; the HAMD17 suicide item was =3 points; 2. With severe or unstable of heart, liver, kidney, endocrine, blood and other body disease; 3. Had a history of epilepsy (except for the history of febrile convulsion); 4. Had electroconvulsive therapy history nearly three months; 5. Bipolar depressive episode; 6. other mental illness or physical disease cause to the depressive episodes; 7. Electrocardiogram or Laboratory results have clinical significant abnormalities. ALT, AST>1.5 times the upper limit of normal,Blood Cr>upper limit of normal; 8. People with alcohol and drug dependence in one year; 9. Have a history of allergy to the drugs; 10. Lactation,pregnancy or have a pregnant plan during the trial; 11. Those who can't follow the doctor's advice; 12. Participated in other clinical trails in a month; 13. With psychotic symptoms; 14. Taking antidepressants within one week(MAOI for 2 weeks,Fluoxetine for 5 weeks); 15. Electrocardiogram or laboratory results have clinical significant abnormalities at the end of 8 weeks of the acute phases; 16. Electrocardiogram or laboratory results have clinical significant abnormalities at the end of 24 weeks of the consolidation phases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficient and Remission rate;Relapse rate and/or time;Recurrence rate and/or time; | — |
Secondary
| Measure | Time frame |
|---|---|
| The deduction rate of kidney Yang deficiency syndrome score in TCM;HAMD17, HAMA compared with baseline;HAMD17 depression mood item score compared with baseline;CGI-S score;CGI - I score;Proportion of the subjects of CGI -s=2;Proportion of the subjects of CGI-I=2 per visit;ASCE score; | — |
Countries
China
Contacts
Public ContactYi Xu
Beijing tongrentang co., LTD
Outcome results
None listed