Major Depression Disorder
Conditions
Keywords
major depressive disorder, Efficacy and safety of buspirone add-one treatment in patients with major depression disorder, buspirone, paroxetine, anxiety
Brief summary
This is a Multicenter, open lable, parallel randomized controlled clinical trial. This study aimed to evaluate the treatment onset time, efficacy and safety in patients with major depressive disorders , accompanying anxiety receiving Buspirone and Paroxetine.
Interventions
DRUGBuspirone
MDD patients with anxiety disorder take paroxetine (20-60mg/d), combining with buspirone (initial dose is 5mg tid, then increase the dose to 10mg tid on 4th day)
DRUGParoxetine
MDD patients with anxiety disorder take paroxetine (20-60mg/d)
Sponsors
Si Tianmei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients meeting Statistical Manual of Mental Disorders IV (DSM-IV) criteria for major depression disorder , Hamilton Depression Rating Scale(HAM-D) score was 17 or above, Hamilton Anxiety Scale（HAMA）score was 7 or above. 2. aged 18-65 years( including 18,65 years ) 3. male and female and inpatient as well as outpatient. 4. Written informed consent was obtained from each patient before therapy. -
Exclusion criteria
1. Patients with pregnant or breast-feeding and not taking effective contraceptive measures 2. Patients were allergic to buspirone or with a known intolerance to contraindication 3. Patients with clinically severe and unstable disease ,and not suitable to participate the study judged by the investigators 4. Patients with nervous system diseases(such as epilepsy, Brain injury, Multiple Sclerosis, Degenerative disease including acute lateral sclerosis, Parkinson's disease, ataxy) 5. Patients with a mental illness according to the DSM-IV, such as Organic mental disorders, Schizophrenia, Shizoaffective disorder, delusional disorder, Undifferentiated schizophrenia, bipolar disorder, and patients with a history of substance abuse including alcohol and active drug within 12 months of screening. 6. Patients are taking other Psychiatric drugs (such as Antipsychotic drugs, Anticonvulsant and Mood stabilizer but not include Antihistamine agents) and receiving ECT that might be excluded. 7. Patients worked on professional drivers or dangerous works 8. Patients participated in clinical trials within the past 30 days and treated with drugs from sponsors are not eligible. 9. Patients with clinically significant abnormalities on electrocardiogram or laboratory tests 10. Patients with Acute Angle-closure Glaucoma 11. Patients with Myasthenia Gravis 12. Patients who have used Monoamine oxidase inhibitors (MAOI) within 2 weeks of Screening 13. Patients who were Refractory depression invalid or non-responsive to adequate dosage (therapeutic dose upper limit) and duration (up 6 weeks) with two or above different antidepressants. 14. Patients who pose a suicidal risk, HAMD suicide score was 3 or above . -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of onset of effect | 8 weeks | defined as ≥20% change in HAMD total scores |
| clinical response rate | 8 weeks | defined as ≥50% change in HAMD total scores |
| remission rate | 8 weeks | Defined as HAMD total score ≤10. |
Secondary
| Measure | Time frame |
|---|---|
| Changes of HAMD scores at week 4 and week 8 compared with baseline | 4 weeks |
| Changes of HAMA scores at week 4 and week 8 compared with baseline | 4 weeks |
Countries
China
Outcome results
None listed