SchizophreniaPhase 3NCT01516424

Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone

A Phase 3 study testing Blonanserin and Risperidone in people with Schizophrenia, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 16 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Schizophrenia
What is being tested?: Blonanserin and Risperidone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 267 participants
Where: 16 sitesChina
Study dates: Feb 2012to Feb 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-Text Revision(TR) criteria for a primary diagnosis of schizophrenia
Patients are 18≤age<65 years of age on the day when informed consent is obtained.
Subject had a PANSS total score ≥70 and 120≥ at Screening
Subject had a score ≥4 on the PANSS at Screening and Baseline.
Subjects are willing and able to comply with study protocol including treatment in hospital.
Subjects or their legal guardians have signed the written informed consent form.

Who cannot join

The subject was treatment with other Investigate product within 30 days.
Subject had a history of treatment with long-acting drug for anti schizophrenia within 56 days.
Subject had a history of treatment with clozapine within 28 days.
Subject With parkinson disease,etc

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

China16 sites

Hebei Province Mental Health Center
Baoding, Hebei, 071000
Beijing Anding Hospital
Beijing, Beijing Municipality, 100088
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, 100096
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100191
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Hunan Province Brain Hospital
Changsha, Hunan, 410007
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Guangzhou Brain Hospital
Guangzhou, Guangdong, 510170
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Nanjing Brain Hospital
Nanjing, Jiangsu, 210029
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300222
Wuxi Mental Health Center
Wuxi, Jiangsu, 214000
Xi'an Mental Health Center
Xi’an, Shanxi, 710061
Henan Provincial Mental Hospital
Xinxiang, Henan, 453002

Other trials in China

About this study

Official title: A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone

Read the detailed description

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone

Trial drugs:

Blonanserin group: Blonanserin tablets+Risperidone mimetic tablets
Risperidone group: Risperidone tablets+Blonanserin mimetic tablets

Objectives of Study :

To evaluate the efficacy and safety of Blonanserin in treating schizophrenia

Conditions: Schizophrenia
Being tested: Blonanserin, Risperidone
Keywords: Blonanserin
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BlonanserinDrug
Also called Lonasen
Blonanserin tablets: 8 - 24mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.
RisperidoneDrug
Also called Risperdal
Risperidone tablets: 2 - 6mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.

Study groups in NCT01516424
Study group	Role	What they receive
Blonanserin	Experimental	Antipsychotics Receives: Drug: Blonanserin
Risperidone	Active comparator	Antipsychotics Receives: Drug: Risperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8
Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 8 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores<70 is the normal,but the scores>120 is more serious.Change=(Week 8 Score - Baseline score)
Measured: From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.

Secondary outcomes (4)

Mean Change in PANSS Subscale Score at the End of Treatment
Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline
Measured: week 8
Mean Change in PANSS 5-factor Model
Mean change in PANSS 5-factor model from baseline at Week 8
Measured: Week 8
Mean Change in PANSS Symptom Scores
Mean change in PANSS symptom scores from baseline at Week 8
Measured: Week 8
Mean Change in PANSS Symptom Scores From Baseline at Each Visit
Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8
Measured: Each Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Feb 2013

First posted24 Jan 2012 (estimated)
Study startFeb 2012
Primary completionFeb 2013
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 267 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01516424
Sponsor's protocol ID: D4906011
Status last verified: May 2018
First submitted: 18 Jan 2012
Last updated: 27 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone
ClinicalTrials.gov ID: NCT01516424
Acronym / sponsor ID: D4906011
Conditions: Schizophrenia
Keywords: Blonanserin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 267 participants (actual)
Lead sponsor: Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 24 Jan 2012 (estimated)
Results: Posted 26 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone

Detailed description

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone

Trial drugs:

Blonanserin group: Blonanserin tablets+Risperidone mimetic tablets
Risperidone group: Risperidone tablets+Blonanserin mimetic tablets

Objectives of Study :

To evaluate the efficacy and safety of Blonanserin in treating schizophrenia

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Blonanserin	Experimental	Drug: BlonanserinAntipsychotics
Risperidone	Active comparator	Drug: RisperidoneAntipsychotics

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Subject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-Text Revision(TR) criteria for a primary diagnosis of schizophrenia
Patients are 18≤age<65 years of age on the day when informed consent is obtained.
Subject had a PANSS total score ≥70 and 120≥ at Screening
Subject had a score ≥4 on the PANSS at Screening and Baseline.
Subjects are willing and able to comply with study protocol including treatment in hospital.

Key exclusion criteria (4 listed)

The subject was treatment with other Investigate product within 30 days.
Subject had a history of treatment with long-acting drug for anti schizophrenia within 56 days.
Subject had a history of treatment with clozapine within 28 days.
Subject With parkinson disease,etc

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
BlonanserinAlso: LonasenBlonanserin tablets: 8 - 24mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.	Drug	Blonanserin
RisperidoneAlso: RisperdalRisperidone tablets: 2 - 6mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.	Drug	Risperidone

Primary outcome

Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8
Time frame: From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.
Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 8 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores<70 is the normal,but the scores>120 is more serious.Change=(Week 8 Score - Baseline score)

4 secondary outcomes

Mean Change in PANSS Subscale Score at the End of Treatment
Time frame: week 8
Mean Change in PANSS 5-factor Model
Time frame: Week 8
Mean Change in PANSS Symptom Scores
Time frame: Week 8
Mean Change in PANSS Symptom Scores From Baseline at Each Visit
Time frame: Each Visit

Results and safety

Results posted to the registry on 26 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Blonanserin	131	96
Risperidone	136	114

Primary outcome: Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8

Time frame: From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.. Mean (Standard Error). Unit: score on a scale

Measure	Blonanserin n = 128	Risperidone n = 133
ITT analysis: At the end of treatment	-30.59 (18.53)	-33.56 (16.89)
PPS analysis: At the end of treatment	-33.71 (17.02)	-36.31 (14.09)

Blonanserin vs Risperidone: Mean Difference (Final Values): 3.69 (95% CI -0.36 to 7.75), p <0.05, ANCOVA
Blonanserin vs Risperidone: Mean Difference (Final Values): 2.94 (95% CI -0.76 to 6.65), p <0.05, ANCOVA

Population analysed: 267 subjects in participant flow, 3 subjects randomized and not treated, 2 subjects does not have baseline PANSS scale, 1 subject take Blonanserin, which randomized to Risperidone group and no PANSS scale collected after first dose. Those 6 subjects excluded from Baseline Population. The Baseline population have 261 subjects.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Blonanserin	1 of 130 (0.8%)	126 of 130 (96.9%)	Not reported
Risperidone	3 of 134 (2.2%)	122 of 134 (91%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
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Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
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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.

Niufan Gu, MD principal investigator

Shanghai Mental Health Center

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Blonanserin and Risperidone in people with Schizophrenia, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 16 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 (time frame: From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01516424.

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 27 Nov 2018.