SchizophreniaPhase 2/3NCT01625000
Safety and Efficacy of MP-214 in Patients With Schizophrenia
A Phase 2/3 study testing MP-214 3mg, MP-214 6mg and MP-214 9mg in people with Schizophrenia, run by Tanabe Pharma Corporation at 3 sites in 3 countries.
Trial summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- MP-214 3mg, MP-214 6mg and MP-214 9mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 512 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 2012to Oct 2015
- Phase
- Phase 2/3
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent obtained from the patient before the initiation of any study-specific procedures
- Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
- Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)
Who cannot join
- Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
- The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Double-Blind, Placebo-Controlled Study of MP-214 in Patients With Schizophrenia
The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- MP-214 3mg, MP-214 6mg, MP-214 9mg, Risperidone 4mg, Placebo
- Keywords
- Schizophrenia, Antipsychotic Agents, Acute Schizophrenia, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Risperidone, Central Nervous System Agents
- Medical subject headings
- Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP-214 3mgDrug
Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
MP-214 6mgDrug
Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
MP-214 9mgDrug
Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
Risperidone 4mgDrug
Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
PlaceboDrug
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| MP-214 3mg | Experimental | Not described Receives: Drug: MP-214 3mg |
| MP-214 6mg | Experimental | Not described Receives: Drug: MP-214 6mg |
| MP-214 9mg | Experimental | Not described Receives: Drug: MP-214 9mg |
| Risperidone 4mg | Active comparator | Not described Receives: Drug: Risperidone 4mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.
Measured: Baseline and Week 6
Secondary outcomes (1)
Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6
CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill).
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2015
- Study completionOct 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625000
- Sponsor's protocol ID
- A002-A4
- Status last verified
- Dec 2025
- First submitted
- 19 Jun 2012
- Last updated
- 5 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of MP-214 in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01625000
- Acronym / sponsor ID
- A002-A4
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Antipsychotic Agents, Acute Schizophrenia, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Risperidone, Central Nervous System Agents
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Posted 12 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MP-214 3mg | Experimental | Drug: MP-214 3mg |
| MP-214 6mg | Experimental | Drug: MP-214 6mg |
| MP-214 9mg | Experimental | Drug: MP-214 9mg |
| Risperidone 4mg | Active comparator | Drug: Risperidone 4mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Written informed consent obtained from the patient before the initiation of any study-specific procedures
- Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
- Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)
Key exclusion criteria (2 listed)
- Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
- The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| MP-214 3mgPatients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks. | Drug | MP-214 3mg |
| MP-214 6mgPatients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks. | Drug | MP-214 6mg |
| MP-214 9mgPatients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks. | Drug | MP-214 9mg |
| Risperidone 4mgPatients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks. | Drug | Risperidone 4mg |
| PlaceboPatients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. | Drug | Placebo |
Primary outcome
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
Time frame: Baseline and Week 6
PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.
1 secondary outcome
Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6
Time frame: Baseline and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MP-214 3mg, MP-214 6mg and MP-214 9mg in people with Schizophrenia, run by Tanabe Pharma Corporation at 3 sites in 3 countries.
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 3 inclusion and 2 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 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan, South Korea, Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 Apr 2021). 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 in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (time frame: Baseline and Week 6). 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 5 Jan 2026.