Major Depressive Disorder
Conditions
Interventions
Treatment Group:Cordycepin conjunct Duloxetine
Placebo Group:Duloxetine conjunct placebo
Sponsors
Beijing Anding Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Outpatient patients, aged 18 to 65 years old male and female; 2) Meet criteria for DSM-IV Major Depressive Disorder; 3) HAMD-17 = 17 on screening and baseline assessment; 4) AIS >6; 5) Understand and willing to sign informed consent form.
Exclusion criteria
Exclusion criteria: 1) Meet DSM-IV diagnostic criteria for other psychiatric disorders; 2) Suicidal risk or the third HAMD-17 item (suicide assessment) =3; 3) Depressive episodes with psychotic symptoms (delusions, hallucinations); 4) Patients who had previously been treated with duloxetine were ineffective; 5) Alcohol or drug abuse or dependence in the first 6 months of screening; 6) With severe or unstable somatic diseases, including cardiovascular disease, cancer, kidney, respiratory, endocrine (including abnormal thyroid function), digestion, blood (such as bleeding) or nervous system disease; 7) With history of epilepsy, except those convulsion caused by febrile convulsion in children; 8) Laboratory examination has important abnormalities such as abnormal liver function tests (ALT and AST 2 times more than normal); renal insufficiency (mean creatinine 2mg/dl or greater than or equal to 177umol/l) on screening; 9) There were clinically significant abnormalities in ECG screening during the screening period, and the researchers considered inappropriate conditions, such as male QTc interval >450 MS, female QTc interval >470 MS (ECG); 10) History of elevated intraocular pressure or history of narrow angle glaucoma; 11) Screened patients who had undergone psychiatric surgery in the first 1 years; 12) 3 months before the screening, electric convulsive treatment, transcranial magnetic stimulation treatment, phototherapy; 13) People who have been allergic to cordycepin and / or duloxetine, or have severe allergies, or at least 2 drug allergies (including light allergy); 14) Systematic psychotherapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy) was carried out within the first 3 months of screening; 15) The use of monoamine oxidase inhibitors (MAOIs) in the first 2 weeks of screening; 16) Patients who had been treated with fluoxetine within the first 1 months of screening; 17) Antipsychotic drugs, antidepressants and mood stabilizers are being used, with a baseline washout period of less than 5 half lives; 18) Continue to take the traditional Chinese medicine, melatonin, Saint John grass and other factors that may affect the central nervous system after screening; 19) 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; 20) Cannot take medicine according to doctor's order; 21) Participants who participated in other clinical trials within the first 3 months of screening; 22) Using cordycepin; 23) Researchers found that patients who were not eligible for other conditions in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Athens Insomnia Scale, AIS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale for Depression- 17-item, HAMD17;Insight and Treatment Attitude Questionnaire, ITAQ;Arizona Sexual Experience Scale,ASEX;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;Clinical Global Impression, CGI;Sheehan Disability Scale, SDS;EEG, ERP; | — |
Countries
China
Contacts
Public ContactGang Wang
Beijing Anding Hospital Capital Medical University
Outcome results
None listed