Randomized，Controlled and Open-label Study of Buspirone add-on Treatment in Patients With Major Depression Disorder
NCT ID: NCT02273154
Last Updated: 2014-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
240 participants
INTERVENTIONAL
2014-08-31
2015-12-31
Brief Summary
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This study aimed to evaluate the treatment onset time, efficacy and safety in patients with major depressive disorders , accompanying anxiety receiving Buspirone and Paroxetine.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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paroxetine and buspirone group
receive paroxetine (20-60mg/d) and buspirone(30mg/d)
Buspirone
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)
Paroxetine
MDD patients with anxiety disorder take paroxetine (20-60mg/d)
paroxetine group
receive paroxetine (20-60mg/d)
Paroxetine
MDD patients with anxiety disorder take paroxetine (20-60mg/d)
Interventions
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Buspirone
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)
Paroxetine
MDD patients with anxiety disorder take paroxetine (20-60mg/d)
Eligibility Criteria
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Inclusion Criteria
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
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 . -
18 Years
65 Years
ALL
No
Sponsors
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Si Tianmei
OTHER
Responsible Party
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Si Tianmei
Professor
Locations
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Institute of mental health, Peking University
Beijing, Beijing Municipality, China
Henan mental health center
Xinxiang, Henan, China
Wuhan mental health center
Wuhan, Hubei, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Dalian No.7 People's Hospital
Dalian, Liaoning, China
Shanxi Dayi Hospital
Taiyuan, Shanxi, China
Countries
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Facility Contacts
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Other Identifiers
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BUS-IV-01
Identifier Type: -
Identifier Source: org_study_id
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