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

Major Depression Disorder Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02273154
• Other study ID #: BUS-IV-01
• Status: Recruiting
• Phase: Phase 4
• First received: October 21, 2014
• Last updated: October 22, 2014
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2014
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression Disorder

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
China	Institute of mental health, Peking University	Beijing	Beijing
China	Dalian No.7 People's Hospital	Dalian	Liaoning
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	Shanxi Dayi Hospital	Taiyuan	Shanxi
China	Wuhan mental health center	Wuhan	Hubei
China	Henan mental health center	Xinxiang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Si Tianmei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of onset of effect	defined as =20% change in HAMD total scores	8 weeks	Yes
Primary	clinical response rate	defined as =50% change in HAMD total scores	8 weeks	Yes
Primary	remission rate	Defined as HAMD total score =10.	8 weeks	Yes
Secondary	Changes of HAMD scores at week 4 and week 8 compared with baseline		4 weeks	Yes
Secondary	Changes of HAMA scores at week 4 and week 8 compared with baseline		4 weeks	Yes