SchizophreniaPhase 3NCT02002832

A Clinical Trial of Lurasidone in Treatment of Schizophrenia

A Phase 3 study testing Lurasidone tablets and Risperidone tablets in people with Schizophrenia, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 15 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

This is a randomized, double-blind, double-dummy, parallel- controlled, adjustable dose, non-inferiority and multicentre study designed to evaluate the efficacy and safety of lurasidone on schizophrenia for 6 weeks treatment, and to compare with risperidone. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: Lurasidone tablets and Risperidone tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 388 participants
Where: 15 sitesChina
Study dates: Dec 2013to Nov 2015
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide written informed consent and aged between 18 and 65 years of age.
Meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia, had a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, and a score ≥ 4 on the CGI-S at Screening and Baseline.
Not pregnant, if of reproductive potential agrees to use adequate and reliable contraception for duration of study.
Able and agrees to remain off prior antipsychotic medication for the duration of study.
Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Who cannot join

Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
Any chronic organic disease of the CNS(other than schizophrenia)
Subjects are participating or participated in other clinical studies including marketed drugs or medical devices within 30 days before signing the informed consent form.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

China15 sites

HeBei Mental Health Center
Baoding, Hebei, 071000
Capital Medical University Affiliated 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, 510370
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-blind, Double-dummy, Parallel-group and Multicenter Study to Investigate Lurasidone in Treatment of Schizophrenia Compared With Risperidone

Conditions: Schizophrenia
Being tested: Lurasidone tablets, Risperidone tablets
Keywords: schizophrenia, Lurasidone, LATUDA
Medical subject headings: Schizophrenia

What participants receive

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

Lurasidone tabletsDrug
Also called LATUDA
Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo)
Risperidone tabletsDrug
Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)

Study groups in NCT02002832
Study group	Role	What they receive
Lurasidone group	Experimental	Not described Receives: Drug: Lurasidone tablets
Risperidone group	Active comparator	Not described Receives: Drug: Risperidone tablets

What is being measured

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

Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.
Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 6 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.
Measured: From baseline to Week 6(day 42).

Secondary outcomes (1)

Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.
The Clinical Global Impression Scale-Improvement (CGI-I) Score is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to baseline state at the beginning of the intervention. Response is rated as one of the following, in which higher scores indicate less improvement or worsening:
1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.
Measured: From baseline to Week 6(day 42).

Timeline

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

Dec 2013Nov 2015

First posted6 Dec 2013 (estimated)
Study startDec 2013
Primary completionApr 2015
Study completionNov 2015

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: 388 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02002832
Sponsor's protocol ID: D1070004
Status last verified: May 2018
First submitted: 2 Dec 2013
Last updated: 15 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Double-dummy, Parallel-group and Multicenter Study to Investigate Lurasidone in Treatment of Schizophrenia Compared With Risperidone
ClinicalTrials.gov ID: NCT02002832
Acronym / sponsor ID: D1070004
Conditions: Schizophrenia
Keywords: schizophrenia, Lurasidone, LATUDA
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 388 participants (actual)
Lead sponsor: Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Apr 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 6 Dec 2013 (estimated)
Results: Posted 1 Apr 2019

Clinical summary

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

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
Lurasidone group	Experimental	Drug: Lurasidone tablets
Risperidone group	Active comparator	Drug: Risperidone tablets

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Provide written informed consent and aged between 18 and 65 years of age.
Meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia, had a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, and a score ≥ 4 on the CGI-S at Screening and Baseline.
Not pregnant, if of reproductive potential agrees to use adequate and reliable contraception for duration of study.
Able and agrees to remain off prior antipsychotic medication for the duration of study.
Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Key exclusion criteria (4 listed)

Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
Any chronic organic disease of the CNS(other than schizophrenia)
Subjects are participating or participated in other clinical studies including marketed drugs or medical devices within 30 days before signing the informed consent form.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

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
Lurasidone tabletsAlso: LATUDALurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo)	Drug	Lurasidone group
Risperidone tabletsRisperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)	Drug	Risperidone group

Primary outcome

Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.
Time frame: From baseline to Week 6(day 42).
Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 6 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.

1 secondary outcome

Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.
Time frame: From baseline to Week 6(day 42).

Results and safety

Results posted to the registry on 1 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lurasidone Group	194	166
Risperidone Group	194	168

Primary outcome: Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.

Time frame: From baseline to Week 6(day 42).. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Lurasidone Group n = 194	Risperidone Group n = 190
Value	-31.2 (-33.2 to -29.2)	-34.9 (-36.8 to -32.9)

Lurasidone Group vs Risperidone Group: Mean Difference (Final Values): 3.7 (95% CI 1.0 to 6.3), Mixed Models Analysis

Population analysed: Intent-to-Treat population: All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lurasidone Group	1 of 194 (0.5%)	134 of 194 (69.1%)	0 of 194
Risperidone Group	0 of 191 (0%)	160 of 191 (83.8%)	0 of 191

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Schizophrenia

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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
Schizophrenia, Autism-Related Irritability
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
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
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Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
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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.

Zhuoji CAI, MD principal investigator

Capital Medical University Affiliated Beijing Anding Hospital

15 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 Lurasidone tablets and Risperidone tablets in people with Schizophrenia, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 15 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 5 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 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 1 Apr 2019). 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?

Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores. (time frame: From baseline to Week 6(day 42).). 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 NCT02002832.

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 15 Nov 2019.