NCT01625000

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline
Completed

Started May 2012

Typical duration for phase_2 schizophrenia

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

April 12, 2021

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

3.3 years

First QC Date

June 19, 2012

Results QC Date

January 11, 2021

Last Update Submit

December 15, 2025

Conditions

Schizophrenia

Keywords

SchizophreniaAntipsychotic AgentsAcute SchizophreniaMental DisorderPsychotropic DrugsDopamine AgentsRisperidoneCentral Nervous System Agents

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and Week 6

Secondary Outcomes (1)

  • Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6

    Baseline and Week 6

Study Arms (5)

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

Interventions

MP-214 3mgDRUG

Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.

MP-214 3mg
MP-214 6mgDRUG

Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.

MP-214 6mg
MP-214 9mgDRUG

Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.

MP-214 9mg
Risperidone 4mgDRUG

Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.

Risperidone 4mg
PlaceboDRUG

Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.

Placebo

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Taipei, Taiwan

Location

MeSH Terms

Conditions

SchizophreniaMental Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Clinical Trials, Information Desk
Organization
Tanabe Pharma Corporation
cti-inq-ml.JP@ml.tanabe-pharma.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 21, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

January 5, 2026

Results First Posted

April 12, 2021

Record last verified: 2025-12

Locations

TW(1)KR(1)JP(1)