Schizophrenia
Conditions
Keywords
Schizophrenia, Antipsychotic Agents, Acute Schizophrenia, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Risperidone, Central Nervous System Agents
Brief summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.
Interventions
DRUGMP-214 3mg
Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
DRUGMP-214 6mg
Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
DRUGMP-214 9mg
Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
DRUGRisperidone 4mg
Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
DRUGPlacebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 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 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 | Description |
|---|---|---|
| Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 | Baseline and Week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6 | Baseline and Week 6 | 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). |
Countries
Japan, South Korea, Taiwan
Participant flow
Pre-assignment details
Four subjects withdrew from the study before the start of the study medication after being assigned to the treatment.
Participants by arm
| Arm | Count |
|---|---|
| MP-214 3mg MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks. | 126 |
| MP-214 6mg MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks. | 133 |
| MP-214 9mg MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks. | 67 |
| Risperidone 4mg Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks. | 56 |
| Placebo Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. | 126 |
| Total | 508 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event (including Death) | 15 | 19 | 11 | 7 | 21 |
| Overall Study | Physician Decision | 15 | 7 | 7 | 2 | 15 |
| Overall Study | Protocol Violation | 3 | 10 | 4 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 19 | 16 | 11 | 9 | 17 |
Baseline characteristics
| Characteristic | MP-214 3mg | MP-214 6mg | MP-214 9mg | Risperidone 4mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 40.6 years STANDARD_DEVIATION 10.6 | 40.2 years STANDARD_DEVIATION 11.4 | 43.0 years STANDARD_DEVIATION 9.7 | 39.5 years STANDARD_DEVIATION 10.2 | 40.1 years STANDARD_DEVIATION 11.1 | 40.6 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 60 Participants | 60 Participants | 34 Participants | 25 Participants | 66 Participants | 245 Participants |
| Sex: Female, Male Male | 66 Participants | 73 Participants | 33 Participants | 31 Participants | 60 Participants | 263 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 95 / 126 | 100 / 133 | 52 / 67 | 36 / 56 | 72 / 126 |
| serious Total, serious adverse events | 12 / 126 | 16 / 133 | 4 / 67 | 2 / 56 | 14 / 126 |
Outcome results
Primary
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
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.
Time frame: Baseline and Week 6
Population: For OC (Observed Case) analysis, the Missing Values were Not included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| MP-214 3mg | Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 | -10.4 units on a scale | Standard Error 2 |
| MP-214 6mg | Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 | -13.8 units on a scale | Standard Error 2 |
| MP-214 9mg | Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 | -14.0 units on a scale | Standard Error 2.9 |
| Risperidone 4mg | Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 | -20.2 units on a scale | Standard Error 3 |
| Placebo | Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 | -9.5 units on a scale | Standard Error 2.1 |
Secondary
Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6
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).
Time frame: Baseline and Week 6
Population: For OC (Observed Case) analysis, the Missing Values were Not included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| MP-214 3mg | Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6 | -0.7 units on a scale | Standard Error 0.1 |
| MP-214 6mg | Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6 | -0.8 units on a scale | Standard Error 0.1 |
| MP-214 9mg | Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6 | -0.7 units on a scale | Standard Error 0.2 |
| Risperidone 4mg | Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6 | -1.2 units on a scale | Standard Error 0.2 |
| Placebo | Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6 | -0.6 units on a scale | Standard Error 0.1 |