Status:
UNKNOWN
Randomized，Controlled and Open-label Study of Buspirone add-on Treatment in Patients With Major Depression Disorder
Lead Sponsor:
Si Tianmei
Conditions:
Major Depression Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 disorder...
Eligibility Criteria
Inclusion
- 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.
- aged 18-65 years( including 18,65 years )
- male and female and inpatient as well as outpatient.
- Written informed consent was obtained from each patient before therapy. -
Exclusion
- Patients with pregnant or breast-feeding and not taking effective contraceptive measures
- Patients were allergic to buspirone or with a known intolerance to contraindication
- Patients with clinically severe and unstable disease ,and not suitable to participate the study judged by the investigators
- Patients with nervous system diseases(such as epilepsy, Brain injury, Multiple Sclerosis, Degenerative disease including acute lateral sclerosis, Parkinson's disease, ataxy)
- 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.
- 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.
- Patients worked on professional drivers or dangerous works
- Patients participated in clinical trials within the past 30 days and treated with drugs from sponsors are not eligible.
- Patients with clinically significant abnormalities on electrocardiogram or laboratory tests
- Patients with Acute Angle-closure Glaucoma
- Patients with Myasthenia Gravis
- Patients who have used Monoamine oxidase inhibitors (MAOI) within 2 weeks of Screening
- 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.
- Patients who pose a suicidal risk, HAMD suicide score was 3 or above . -
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT02273154
Start Date
August 1 2014
End Date
December 1 2015
Last Update
October 23 2014
Active Locations (6)
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1
Institute of mental health, Peking University
Beijing, Beijing Municipality, China, 100191
2
Henan mental health center
Xinxiang, Henan, China, 453000
3
Wuhan mental health center
Wuhan, Hubei, China, 430000
4
Nanjing Brain Hospital
Nanjing, Jiangsu, China, 210000