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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273154
Recruitment Status : Unknown
Verified October 2014 by Si Tianmei, Peking University.
Recruitment status was:  Recruiting
First Posted : October 23, 2014
Last Update Posted : October 23, 2014
Sponsor:
Information provided by (Responsible Party):
Si Tianmei, Peking University

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.


Condition or disease Intervention/treatment Phase
Major Depression Disorder Drug: Buspirone Drug: Paroxetine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015


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)




Primary Outcome Measures :
  1. Rate of onset of effect [ Time Frame: 8 weeks ]
    defined as ≥20% change in HAMD total scores

  2. clinical response rate [ Time Frame: 8 weeks ]
    defined as ≥50% change in HAMD total scores

  3. remission rate [ Time Frame: 8 weeks ]
    Defined as HAMD total score ≤10.


Secondary Outcome Measures :
  1. Changes of HAMD scores at week 4 and week 8 compared with baseline [ Time Frame: 4 weeks ]
  2. Changes of HAMA scores at week 4 and week 8 compared with baseline [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 . -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273154


Locations
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China, Beijing
Institute of mental health, Peking University Not yet recruiting
Beijing, Beijing, China, 100191
Contact: Tianmei Si, PhD.    8610-82801960    si.tian-mei@163.com   
Principal Investigator: Tianmei Si, PhD.         
China, Henan
Henan mental health center Recruiting
Xinxiang, Henan, China, 453000
Contact: Luxian Lv, MD.    86-13837320007    lvluxian86@hotmail.com   
China, Hubei
Wuhan mental health center Recruiting
Wuhan, Hubei, China, 430000
Contact: Maosheng Fang, MD.    86-13553013182    fangmaosheng@126.com   
China, Jiangsu
Nanjing Brain Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Zhijian Yao, PhD.    86-13851580276    zhijianyao@163.com   
China, Liaoning
Dalian No.7 People's Hospital Recruiting
Dalian, Liaoning, China, 116000
Contact: Shoufu Xie, MD.    86-18441168381    shoufuxie@126.com   
China, Shanxi
Shanxi Dayi Hospital Recruiting
Taiyuan, Shanxi, China, 030000
Contact: Hong Yang, MD.    86-13903414208    hongyang1964@163.com   
Sponsors and Collaborators
Si Tianmei

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Responsible Party: Si Tianmei, Professor, Peking University
ClinicalTrials.gov Identifier: NCT02273154    
Other Study ID Numbers: BUS-IV-01
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: October 23, 2014
Last Verified: October 2014
Keywords provided by Si Tianmei, Peking University:
major depressive disorder
Efficacy and safety of buspirone add-one treatment in patients with major depression disorder
buspirone
paroxetine
anxiety
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Buspirone
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Serotonin Receptor Agonists