Major Depressive Disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Outpatient patients, age from 18 to 65 years old, no gender limitation; 2) Meet criteria for DSM-IV Major Depressive Disorder; 3) HAMD-17 = 17 on screening and baseline assessment; 4) Understand and willing to sign informed consent form
Exclusion criteria
Exclusion criteria: 1) Meet any other criteria for DSM-IV Disorders; 2) Suicidal risk or the third HAMD-17 item (suicide assessment) =3; 3) Alchohol or drug abuse or dependence in 6 months before screening; 4) With sever or unstable body disease, including any cardiovascular, tumor, kidney, respiratory, endocrine (including thyroid dysfunction), digestion, blood (such as bleeding tendency) or nervous system diseases; 5) Bleeding tendency or nervous system diseases; 5)With history of epilepsy, except those convulsion caused by febrile convulsion in children; 6) Screened patients who had undergone psychiatric surgery in the first 1 years; 7) 3 months before the screening, electric convulsive treatment, transcranial magnetic stimulation treatment, phototherapy; 8) Antipsychotic drugs, antidepressants and mood stabilizers are being used, with a baseline washout period of less than 5 half lives; 9) Men and women who have fertility requirements (including men) during lactation, pregnancy or during pregnancy, as well as men and women who are unable to carry out safe and effective contraception; 10) Cannot take medicine according to doctor's order; 11) Participants who participated in other clinical trials within the first 3 months of screening; 12) Researchers found that patients who were not eligible for other conditions in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale for Depression- 17-item, HAMD17; | — |
Secondary
| Measure | Time frame |
|---|---|
| Athens Insomnia Scale, AIS;Perceived Deficits Questionnaire-Depression, PDQ-D;The Digit Symbol Substitution Test, DSST;16-item Quick Inventory of Depressive Symptomatology Self-Report Scale, QIDS-SR16;The 7-item Generalized Anxiety Disorder Scale, GAD-7;Sheehan Disability Scale, SDS;ERP; | — |
Countries
China
Contacts
Beijing Anding Hospital Capital Medical University