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

Phase 4

• Conditions: Major Depression Disorder
• Interventions: Drug: Buspirone; Drug: Paroxetine

• Registration Number: NCT02273154
• Lead Sponsor: Si Tianmei

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Status Verified: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-22
• Last Update Submitted: 2014-10-22
• Study First Posted: 2014-10-23
• Last Update Posted: 2014-10-23
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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 . -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paroxetine and buspirone group	Buspirone	receive paroxetine (20-60mg/d) and buspirone(30mg/d)
paroxetine and buspirone group	Paroxetine	receive paroxetine (20-60mg/d) and buspirone(30mg/d)
paroxetine group	Paroxetine	receive paroxetine (20-60mg/d)

Primary Outcome Measures

Name	Time	Method
clinical response rate	8 weeks	defined as ≥50% change in HAMD total scores
remission rate	8 weeks	Defined as HAMD total score ≤10.
Rate of onset of effect	8 weeks	defined as ≥20% change in HAMD total scores

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Henan mental health center; 🇨🇳 Xinxiang, Henan, China

Institute of mental health, Peking University; 🇨🇳 Beijing, Beijing, 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