Schizophrenia
Conditions
Keywords
Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Risperidone, Central Nervous System Agents
Brief 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.
Interventions
DRUGMP-214
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
DRUGRisperidone
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to 60 weeks |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MP-214 1.5-9mg Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214 | 83 |
| Risperidone 2-12mg Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone | 42 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 27 | 10 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 25 | 3 |
Baseline characteristics
| Characteristic | MP-214 1.5-9mg | Risperidone 2-12mg | Total |
|---|---|---|---|
| Age, Customized >=20 and <65 years | 66 Participants | 32 Participants | 98 Participants |
| Age, Customized >=65 and <74 years | 17 Participants | 10 Participants | 27 Participants |
| Sex: Female, Male Female | 44 Participants | 18 Participants | 62 Participants |
| Sex: Female, Male Male | 39 Participants | 24 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 72 / 83 | 39 / 42 |
| serious Total, serious adverse events | 13 / 83 | 4 / 42 |
Outcome results
Primary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 60 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MP-214 1.5-9mg | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 78 Participants |
| Risperidone 2-12mg | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 42 Participants |