Clinical trial NCT00862992: Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia
Official title: Phase II Study of MP-214 in Patients With Schizophrenia (Exploratory Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: schizophrenia
antipsychotics
dopamine D3/D2 antagonist
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2009-03-17
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Event and Adverse Drug Reaction
timeFrame: Up to 7 weeks
Secondary outcomes:
measure: Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14
timeFrame: Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.
measure: Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14
timeFrame: Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.
measure: 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
timeFrame: Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.
Other outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 14 (Last Observation Carried Forward; LOCF)
timeFrame: at baseline, and on Day 14 or a last observation carried forward (LOCF)
measure: Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Day 14 (Last Observation Carried Forward; LOCF)
timeFrame: at baseline, and on Day 14 or a last observation carried forward (LOCF)
measure: The Clinical Global Impression-Improvement (CGI-I) Score at Day 14 (Last Observation Carried Forward; LOCF)
timeFrame: on Day 14 or a last observation carried forward (LOCF)
Locations:
city: Kure-City
country: Japan
facility: Hoyu Hospital
state: Hiroshima-ken
Study officials:
affiliation: National Center of Neurology and Psychiatry
name: Teruhiko Higuchi, President
role: STUDY_CHAIR
References: