Randomized，Controlled and Open-label Study of Buspirone add-on Treatment in Patients With Major Depression Disorder

Study Overview
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Brief Summary
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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.

Conditions
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Major Depression Disorder

Intervention / Treatment
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* Drug: Buspirone
* Drug: Paroxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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 . -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paroxetine and buspirone group<br>receive paroxetine (20-60mg/d) and buspirone(30mg/d) | Drug: Buspirone<br>* 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)<br>Drug: Paroxetine<br>* MDD patients with anxiety disorder take paroxetine (20-60mg/d)<br>|
| Active Comparator: paroxetine group<br>receive paroxetine (20-60mg/d) | Drug: Paroxetine<br>* MDD patients with anxiety disorder take paroxetine (20-60mg/d)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of onset of effect | defined as ≥20% change in HAMD total scores | 8 weeks | 
| clinical response rate | defined as ≥50% change in HAMD total scores | 8 weeks | 
| remission rate | Defined as HAMD total score ≤10. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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major depressive disorder, Efficacy and safety of buspirone add-one treatment in patients with major depression disorder, buspirone, paroxetine, anxiety