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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paroxetine and buspirone group | Experimental | receive paroxetine (20-60mg/d) and buspirone(30mg/d) |
|
| paroxetine group | Active Comparator | receive paroxetine (20-60mg/d) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buspirone | Drug | 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) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of mental health, Peking University | Not yet recruiting | Beijing | Beijing Municipality | 100191 | China |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002065 | Buspirone |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Paroxetine | Drug | MDD patients with anxiety disorder take paroxetine (20-60mg/d) |
|
| Henan mental health center | Recruiting | Xinxiang | Henan | 453000 | China |
|
| Wuhan mental health center | Recruiting | Wuhan | Hubei | 430000 | China |
|
| Nanjing Brain Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| Dalian No.7 People's Hospital | Recruiting | Dalian | Liaoning | 116000 | China |
|
| Shanxi Dayi Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
|
| D010879 |
| Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |