Major Depression DisorderPhase 4NCT02273154
Randomized，Controlled and Open-label Study of Buspirone add-on Treatment in Patients With Major Depression Disorder
A Phase 4 study testing Buspirone and Paroxetine in people with Major Depression Disorder, run by Si Tianmei at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression Disorder
- What is being tested?
- Buspirone and Paroxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 6 sitesChina
- Study dates
- Aug 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. -
Who cannot join
- 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.
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- 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 . -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Institute of mental health, Peking University
Beijing, Beijing Municipality, 100191
Tianmei Si, PhD., 8610-82801960, si.tian-mei@163.com
Tianmei Si, PhD.
- Recruiting
Dalian No.7 People's Hospital
Dalian, Liaoning, 116000
Shoufu Xie, MD., 86-18441168381, shoufuxie@126.com
- Recruiting
Nanjing Brain Hospital
Nanjing, Jiangsu, 210000
Zhijian Yao, PhD., 86-13851580276, zhijianyao@163.com
- Recruiting
Shanxi Dayi Hospital
Taiyuan, Shanxi, 030000
Hong Yang, MD., 86-13903414208, hongyang1964@163.com
- Recruiting
Wuhan mental health center
Wuhan, Hubei, 430000
Maosheng Fang, MD., 86-13553013182, fangmaosheng@126.com
- Recruiting
Henan mental health center
Xinxiang, Henan, 453000
Luxian Lv, MD., 86-13837320007, lvluxian86@hotmail.com
About this study
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
- Being tested
- Buspirone, Paroxetine
- Keywords
- major depressive disorder, Efficacy and safety of buspirone add-one treatment in patients with major depression disorder, buspirone, paroxetine, anxiety
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuspironeDrug
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)
ParoxetineDrug
MDD patients with anxiety disorder take paroxetine (20-60mg/d)
| Study group | Role | What they receive |
|---|---|---|
| paroxetine and buspirone group | Experimental | receive paroxetine (20-60mg/d) and buspirone(30mg/d) Receives: Drug: Buspirone; Drug: Paroxetine |
| paroxetine group | Active comparator | receive paroxetine (20-60mg/d) Receives: Drug: Paroxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of onset of effect
defined as ≥20% change in HAMD total scores
Measured: 8 weeks
clinical response rate
defined as ≥50% change in HAMD total scores
Measured: 8 weeks
remission rate
Defined as HAMD total score ≤10.
Measured: 8 weeks
Secondary outcomes (2)
Changes of HAMD scores at week 4 and week 8 compared with baseline
Measured: 4 weeks
Changes of HAMA scores at week 4 and week 8 compared with baseline
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depression DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Si Tianmei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Si Tianmei, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273154
- Sponsor's protocol ID
- BUS-IV-01
- Status last verified
- Oct 2014
- First submitted
- 21 Oct 2014
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized，Controlled and Open-label Study of Buspirone add-on Treatment in Patients With Major Depression Disorder
- ClinicalTrials.gov ID
- NCT02273154
- Acronym / sponsor ID
- BUS-IV-01
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Si TianmeiUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paroxetine and buspirone group | Experimental | Drug: Buspirone, Drug: Paroxetinereceive paroxetine (20-60mg/d) and buspirone(30mg/d) |
| paroxetine group | Active comparator | Drug: Paroxetinereceive paroxetine (20-60mg/d) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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. -
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuspironeMDD 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 and buspirone group |
| ParoxetineMDD patients with anxiety disorder take paroxetine (20-60mg/d) | Drug | paroxetine and buspirone group, paroxetine group |
Primary outcome
Rate of onset of effect
Time frame: 8 weeks
defined as ≥20% change in HAMD total scores
clinical response rate
Time frame: 8 weeks
defined as ≥50% change in HAMD total scores
remission rate
Time frame: 8 weeks
Defined as HAMD total score ≤10.
2 secondary outcomes
Changes of HAMD scores at week 4 and week 8 compared with baseline
Time frame: 4 weeks
Changes of HAMA scores at week 4 and week 8 compared with baseline
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buspirone and Paroxetine in people with Major Depression Disorder, run by Si Tianmei at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of onset of effect (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2014; AzTrials last refreshed its copy on 2 Nov 2026.