SchizophreniaPhase 2/3NCT01625897
A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia
A Phase 2/3 study testing MP-214 and Risperidone in people with Schizophrenia, run by Tanabe Pharma Corporation at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with chronic phase or elderly schizophrenia. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- MP-214 and Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteJapan
- Study dates
- May 2012to Mar 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older 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 who meet at least one of the following:
- current diagnosis of schizophrenia of chronic phase
- between 65 and 74 years of age
- 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
1 site in 1 country.
About this study
Official title: A Long-term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with chronic phase or elderly schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- MP-214, Risperidone
- Keywords
- Schizophrenia, Antipsychotic Agents, 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-214Drug
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
RisperidoneDrug
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
| Study group | Role | What they receive |
|---|---|---|
| MP-214 1.5-9mg | Experimental | Not described Receives: Drug: MP-214 |
| Risperidone 2-12mg | Active comparator | Not described Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: Up to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2015
- Study completionMar 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
- None (open label)
- Enrolment
- 125 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
- NCT01625897
- Sponsor's protocol ID
- A002-A7
- 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 Long-term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia
- ClinicalTrials.gov ID
- NCT01625897
- Acronym / sponsor ID
- A002-A7
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Risperidone, Central Nervous System Agents
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Jun 2012 (estimated)
- Results
- Posted 13 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 long-term safety, tolerability, and efficacy of MP-214 in patients with chronic phase or elderly schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MP-214 1.5-9mg | Experimental | Drug: MP-214 |
| Risperidone 2-12mg | Active comparator | Drug: Risperidone |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 who meet at least one of the following:
- 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-214Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214 | Drug | MP-214 1.5-9mg |
| RisperidonePatients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone | Drug | Risperidone 2-12mg |
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 60 weeks
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MP-214 and Risperidone in people with Schizophrenia, run by Tanabe Pharma Corporation at 1 site in Japan.
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 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 1 site in Japan. 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 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 13 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?
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: Up to 60 weeks). 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.