NCT01626885

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

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
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

April 13, 2021

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

June 19, 2012

Results QC Date

January 11, 2021

Last Update Submit

December 15, 2025

Conditions

Schizophrenia

Keywords

SchizophreniaAntipsychotic AgentsMental DisorderPsychotropic DrugsDopamine AgentsCentral Nervous System Agents

Outcome Measures

Primary Outcomes (1)

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

    Up to 60 weeks

Study Arms (1)

MP-214 1.5-9 mg

EXPERIMENTAL
Drug: MP-214

Interventions

MP-214DRUG

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

MP-214 1.5-9 mg

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 who receive 1 or more antipsychotic drugs
  • 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 (1)

Unknown Facility

Kurayoshi, Tottori, Japan

Location

MeSH Terms

Conditions

SchizophreniaMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 25, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

January 6, 2026

Results First Posted

April 13, 2021

Record last verified: 2025-12

Locations

JP(1)