CClinicalTrials.gg
CompletedNCT01626885Updated Jan 6, 2026Results posted

A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia

A Phase 2/3 interventional study of MP-214 in Schizophrenia, sponsored by Tanabe Pharma Corporation. Completed at 1 site in Japan. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Tanabe Pharma Corporation · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
20 Years to 64 Years
Sex
All
01

Study summary

The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with receiving multiple drugs schizophrenia.

02

Conditions studied

  • Schizophrenia

Keywords

  • Schizophrenia
  • Antipsychotic Agents
  • Mental Disorder
  • Psychotropic Drugs
  • Dopamine Agents
  • Central Nervous System Agents
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 42 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Tanabe Pharma Corporation is the lead sponsor of 91 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 receive 1 or more antipsychotic drugs
  • Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    MP-214 1.5-9 mg

    Drug: MP-214

Interventions

  • DrugMP-214

    Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Time frame: Up to 60 weeks

07

Results

Posted Apr 13, 2021

Participant flow

Participant flow — Overall Study
MilestoneMP-214 1.5-9 mg
Started42
Completed30
Not completed12
Withdrew: Adverse event8
Withdrew: Withdrawal by subject4

Outcome measures

PrimaryNumber of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame:
Up to 60 weeks
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
ParticipantsMP-214 1.5-9 mg
Number of Participants With Adverse Events as a Measure of Safety and Tolerability42

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MP-214 1.5-9 mg—2/42 (4.8%)37/42 (88.1%)
Most frequent serious events
Most frequent serious events
EventMP-214 1.5-9 mg
Type 2 diabetes mellitusMetabolism and nutrition disorders1/42
SchizophreniaPsychiatric disorders1/42
Most frequent other events
Showing 10 of 21
Most frequent other events
EventMP-214 1.5-9 mg
NasopharyngitisInfections and infestations18/42
SchizophreniaPsychiatric disorders8/42
HeadacheNervous system disorders7/42
SomnolenceNervous system disorders7/42
Blood creatine phosphokinase increasedInvestigations6/42
Weight increasedInvestigations6/42
Extrapyramidal disorderNervous system disorders6/42
Alanine aminotransferase increasedInvestigations5/42
InsomniaPsychiatric disorders5/42
NauseaGastrointestinal disorders4/42

Baseline characteristics

Age, Continuous
Age, Continuous(years)MP-214 1.5-9 mg
Mean40.4 ± 10.7
Sex: Female, Male
Sex: Female, Male(Participants)MP-214 1.5-9 mg
Female19
Male23
08

Study locations

1 site
  • Kurayoshi, Tottori, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01626885
Lead sponsor
Tanabe Pharma Corporation
Responsible party
Sponsor
First posted
Jun 25, 2012
Start date
May 2012
Primary completion
Jun 2014
Completion
Jun 2014
Results posted
Apr 13, 2021
Last update
Jan 6, 2026
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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