Phase 3 N=125 Randomized Treatment

A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT01625897 ↗

Enrolled (actual)

125

Serious AEs

13.6%

Results posted

Apr 2021

Primary outcome: Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 78; 42 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: MP-214 (Drug); Risperidone (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Tanabe Pharma Corporation
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability	78; 42	—

Summary

The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with chronic phase or elderly schizophrenia.

Eligibility Criteria

Inclusion Criteria

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 meet at least one of the following:
current diagnosis of schizophrenia of chronic phase
between 65 and 74 years of age
Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01625897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.