Clinical trial NCT02273154: Randomized，Controlled and Open-label Study of Buspirone add-on Treatment in Patients With Major Depression Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depression Disorder
Keywords: major depressive disorder
Efficacy and safety of buspirone add-one treatment in patients with major depression disorder
buspirone
paroxetine
anxiety
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2014-10-23
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 . -

Primary outcomes:
measure: Rate of onset of effect
timeFrame: 8 weeks
measure: clinical response rate
timeFrame: 8 weeks
measure: remission rate
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes of HAMD scores at week 4 and week 8 compared with baseline
timeFrame: 4 weeks
measure: Changes of HAMA scores at week 4 and week 8 compared with baseline
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of mental health, Peking University
state: Beijing
city: Xinxiang
country: China
facility: Henan mental health center
state: Henan
city: Wuhan
country: China
facility: Wuhan mental health center
state: Hubei
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Dalian
country: China
facility: Dalian No.7 People's Hospital
state: Liaoning
city: Taiyuan
country: China
facility: Shanxi Dayi Hospital
state: Shanxi
Study officials:
References: