NCT00862992

Brief Summary

The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets will be administered to patients starting at an initial dose, followed by up-titration to a fixed dose (low, medium or high) for 14 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Apr 2008

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

April 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
11.6 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

1.4 years

First QC Date

March 15, 2009

Results QC Date

January 11, 2021

Last Update Submit

December 15, 2025

Conditions

Schizophrenia

Keywords

schizophreniaantipsychoticsdopamine D3/D2 antagonist

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Event and Adverse Drug Reaction

    Up to 7 weeks

Secondary Outcomes (3)

  • Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14

    Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.

  • Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14

    Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Last of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14

    Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.

Other Outcomes (3)

  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 14 (Last Observation Carried Forward; LOCF)

    at baseline, and on Day 14 or a last observation carried forward (LOCF)

  • Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Day 14 (Last Observation Carried Forward; LOCF)

    at baseline, and on Day 14 or a last observation carried forward (LOCF)

  • The Clinical Global Impression-Improvement (CGI-I) Score at Day 14 (Last Observation Carried Forward; LOCF)

    on Day 14 or a last observation carried forward (LOCF)

Study Arms (3)

1

EXPERIMENTAL
Drug: Cariprazine 3 mg

2

EXPERIMENTAL
Drug: Cariprazine 6 mg

3

EXPERIMENTAL
Drug: Cariprazine 12.5 mg

Interventions

Cariprazine 3 mgDRUG
Also known as: Cariprazine(INN), RGH-188
1
Cariprazine 6 mgDRUG
2
Cariprazine 12.5 mgDRUG
3

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients meeting DSM-IV-TR criteria for schizophrenia
  • PANSS total score \<= 120 during the observation period
  • Patients who have been treated with oral antipsychotics within 4 weeks before informed consent
  • Patients whose consent is obtained from themselves in written form

You may not qualify if:

  • Patients who have defined as any mental disorder other than "Schizophrenia" based on the criteria of DSM-IV-TR
  • History of drug or alcohol abuse
  • Concurrent Parkinson's disease
  • History of, or concurrent spastic disorders like epilepsy, cerebrovascular disease, anuresis or adynamic(= paralytic) ileus, malignant syndrome, diabetes, hepatic disorder
  • Patients who exhibit abnormalities on Physical Examination, have abnormal vital signs, ECG, or clinical laboratory values
  • Current cataract during the observation period
  • History of shock or anaphylactoid symptoms to drugs
  • 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)

Hoyu Hospital

Kure, Hiroshima, Japan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

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

Study Officials

  • Teruhiko Higuchi, President

    National Center of Neurology and Psychiatry

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2009

First Posted

March 17, 2009

Study Start

April 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 5, 2026

Results First Posted

April 12, 2021

Record last verified: 2025-12

Locations

JP(1)