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

NCT02273154 | Unknown Phase 4

• 1 other identifier: BUS-IV-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

paroxetine and buspirone group

EXPERIMENTAL

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

Drug: Buspirone; Drug: Paroxetine

paroxetine group

ACTIVE COMPARATOR

receive paroxetine (20-60mg/d)

Drug: Paroxetine

Interventions

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)

paroxetine and buspirone group

Paroxetine DRUG

MDD patients with anxiety disorder take paroxetine (20-60mg/d)

paroxetine and buspirone group; paroxetine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• aged 18-65 years( including 18,65 years )
• male and female and inpatient as well as outpatient.
• Written informed consent was obtained from each patient before therapy. -

You may not qualify if:

• Patients with pregnant or breast-feeding and not taking effective contraceptive measures
• Patients were allergic to buspirone or with a known intolerance to contraindication
• Patients with clinically severe and unstable disease ,and not suitable to participate the study judged by the investigators
• Patients with nervous system diseases(such as epilepsy, Brain injury, Multiple Sclerosis, Degenerative disease including acute lateral sclerosis, Parkinson's disease, ataxy)
• 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.
• 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.
• Patients worked on professional drivers or dangerous works
• Patients participated in clinical trials within the past 30 days and treated with drugs from sponsors are not eligible.
• Patients with clinically significant abnormalities on electrocardiogram or laboratory tests
• Patients with Acute Angle-closure Glaucoma
• Patients with Myasthenia Gravis
• Patients who have used Monoamine oxidase inhibitors (MAOI) within 2 weeks of Screening
• 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.
• Patients who pose a suicidal risk, HAMD suicide score was 3 or above . -

Sponsors & Collaborators

• Si Tianmei: lead

Study Sites (6)

Institute of mental health, Peking University

Beijing, Beijing Municipality, 100191, China

NOT YET RECRUITING

Henan mental health center

Xinxiang, Henan, 453000, China

RECRUITING

Wuhan mental health center

Wuhan, Hubei, 430000, China

RECRUITING

Nanjing Brain Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Dalian No.7 People's Hospital

Dalian, Liaoning, 116000, China

RECRUITING

Shanxi Dayi Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders

Interventions

Buspirone; Paroxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 23, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 23, 2014

Record last verified: 2014-10

Locations

CN (6)