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

October 22, 2014 updated by: Si Tianmei

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Not yet recruiting
        • Institute of Mental Health, Peking University
        • Contact:
        • Principal Investigator:
          • Tianmei Si, PhD.
    • Henan
      • Xinxiang, Henan, China, 453000
        • Recruiting
        • Henan Mental Health Center
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Wuhan Mental Health Center
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Brain Hospital
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Recruiting
        • Dalian No.7 People's Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Dayi Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: paroxetine and buspirone group
receive paroxetine (20-60mg/d) and buspirone(30mg/d)
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)
Drug: Paroxetine
MDD patients with anxiety disorder take paroxetine (20-60mg/d)
Active Comparator: paroxetine group
receive paroxetine (20-60mg/d)
Drug: Paroxetine
MDD patients with anxiety disorder take paroxetine (20-60mg/d)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of onset of effect
Time Frame: 8 weeks
defined as ≥20% change in HAMD total scores
8 weeks
clinical response rate
Time Frame: 8 weeks
defined as ≥50% change in HAMD total scores
8 weeks
remission rate
Time Frame: 8 weeks
Defined as HAMD total score ≤10.
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes of HAMD scores at week 4 and week 8 compared with baseline
Time Frame: 4 weeks
4 weeks
Changes of HAMA scores at week 4 and week 8 compared with baseline
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Si Tianmei

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 23, 2014

Study Record Updates

Last Update Posted (Estimate)

October 23, 2014

Last Update Submitted That Met QC Criteria

October 22, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUS-IV-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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