Title
Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia
Phase II Study of MP-214 in Patients With Schizophrenia (Exploratory Study)
Phase
Phase 2Lead Sponsor
Mitsubishi TanabeStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
SchizophreniaIntervention/Treatment
cariprazine ...Study Participants
34The 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.
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.
| Event Type | Organ System | Event Term | Cariprazine 3 mg | Cariprazine 6 mg | Cariprazine 12.5 mg |
|---|
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).
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.
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).
