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

Si Tianmei

Status and phase: Unknown; Phase 4

Conditions: Major Depression Disorder

Treatments: Drug: Paroxetine; Drug: Buspirone

Study type: Interventional

Funder types: Other

Identifiers

NCT02273154

BUS-IV-01

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 . -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

paroxetine and buspirone group

Experimental group

Description:

receive paroxetine (20-60mg/d) and buspirone(30mg/d)

Treatment:

Drug: Paroxetine

Drug: Buspirone

paroxetine group

Active Comparator group

Description:

receive paroxetine (20-60mg/d)

Treatment:

Drug: Paroxetine