Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Phase II Study of MP-214 in Patients With Schizophrenia (Exploratory Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862992
• Other study ID #: A002-A3
• Status: Completed
• Phase: Phase 2
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: April 2021
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Cariprazine 3 mg

• Cariprazine 6 mg

• Cariprazine 12.5 mg

Locations

Country	Name	City	State
Japan	Hoyu Hospital	Kure-City	Hiroshima-ken

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 14 (Last Observation Carried Forward; LOCF)	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.	at baseline, and on Day 14 or a last observation carried forward (LOCF)
Other	Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Day 14 (Last Observation Carried Forward; LOCF)	CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill).	at baseline, and on Day 14 or a last observation carried forward (LOCF)
Other	The Clinical Global Impression-Improvement (CGI-I) Score at Day 14 (Last Observation Carried Forward; LOCF)	CGI-I is a 7-point scale to assess the global improvement of the participant's illness relative to baseline. CGI-I scores range from 1 (very much improved) to 7 (very much worse).	on Day 14 or a last observation carried forward (LOCF)
Primary	Number of Participants With Adverse Event and Adverse Drug Reaction		Up to 7 weeks
Secondary	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.
Secondary	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.
Secondary	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.