Acute Schizophrenia, Schizoaffective Disorder
Conditions
Brief summary
The objective of this study is to evaluate the efficacy and safety of RP5063 relative to placebo for the treatment of schizophrenia or schizoaffective disorder.
Interventions
DRUGRP5063
daily
DRUGplacebo
daily
DRUGaripiprazole
daily
Sponsors
Reviva Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients providing informed consent prior to any study specific procedures * Patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), or schizoaffective disorder * Patients with normal physical examination, laboratory, vital signs,and electrocardiogram (ECG)
Exclusion criteria
* Patients with other primary psychiatric disorders as delirium, or bipolar I or II disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline to Day 28 | PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) | Baseline to Day 28 | Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. Scores range from 1 (not ill at all) to 7 (among the most extremely ill). A reduction in score indicates an improvement in the subject's condition. |
| Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale | Baseline to Day 28 | The Positive Scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility) and is calculated by adding the subscale item scores to obtain results ranging from 7 to 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy. |
| Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale | Baseline to Day 28 | The Negative Scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking) and is calculated by adding the negative subscale item scores to obtain results ranging from 7 to 49. Minimum score is 7, maximum score is 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy. |
| Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale | Baseline to Day 28 | The General Psychopathology Scale consists of 16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). The General Psychopathology score is obtained by adding the ratings of each item in the scale, with results ranging from 16 to 112. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy. |
Countries
India, Malaysia, Moldova, Philippines, United States
Participant flow
Recruitment details
270 Subjects with acute exacerbation Schizophrenia and Schizoaffective disorder were selected from multiple sites in USA, Moldova, India, Philippines and Malaysia between December 2011 and January 2013.
Pre-assignment details
Subjects were screened over a period of 7 days in the site's in-patient facility. 270 subjects were recruited. Of these, 36 subjects did not meet the study eligibility criteria. Therefore, a total of 234 subjects were enrolled into the study.
Participants by arm
| Arm | Count |
|---|---|
| RP5063 15 mg Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days. | 58 |
| RP5063 30 mg Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days. | 59 |
| RP5063 50 mg Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days. | 58 |
| Aripiprazole 15 mg Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days. | 20 |
| Placebo Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days. | 38 |
| Total | 233 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Abnormal laboratory findings | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Adverse Event | 0 | 0 | 1 | 2 | 0 |
| Overall Study | Consent withdrawn | 4 | 4 | 3 | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 3 | 1 | 0 | 8 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Non-compliance | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 3 | 4 | 2 | 3 | 1 |
| Overall Study | Subject left hospital | 0 | 1 | 0 | 1 | 0 |
| Overall Study | Subject uncontrollable and abusive | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Worsening of symptoms | 0 | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | RP5063 30 mg | RP5063 50 mg | Aripiprazole 15 mg | RP5063 15 mg |
|---|---|---|---|---|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 12 | 36 years STANDARD_DEVIATION 11 | 37 years STANDARD_DEVIATION 12 | 35 years STANDARD_DEVIATION 9 | 35 years STANDARD_DEVIATION 10 | 36 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 232 Participants | 59 Participants | 58 Participants | 20 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 34 Participants | 208 Participants | 53 Participants | 52 Participants | 18 Participants | 51 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 11 Participants | 3 Participants | 3 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 2 Participants | 12 Participants | 3 Participants | 3 Participants | 1 Participants | 3 Participants |
| Region of Enrollment India | 17 participants | 108 participants | 27 participants | 27 participants | 10 participants | 27 participants |
| Region of Enrollment Malaysia | 8 participants | 42 participants | 11 participants | 10 participants | 3 participants | 10 participants |
| Region of Enrollment Moldova, Republic of | 2 participants | 12 participants | 3 participants | 3 participants | 1 participants | 3 participants |
| Region of Enrollment Philippines | 9 participants | 59 participants | 15 participants | 15 participants | 5 participants | 15 participants |
| Region of Enrollment United States | 2 participants | 12 participants | 3 participants | 3 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 11 Participants | 55 Participants | 9 Participants | 16 Participants | 2 Participants | 17 Participants |
| Sex: Female, Male Male | 27 Participants | 178 Participants | 50 Participants | 42 Participants | 18 Participants | 41 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 | 29 / 58 | 30 / 59 | 37 / 58 | 10 / 20 | 23 / 38 |
| serious Total, serious adverse events | 1 / 58 | 1 / 59 | 1 / 58 | 2 / 20 | 0 / 38 |
Outcome results
Primary
Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score
PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome.
Time frame: Baseline to Day 28
Population: The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RP5063 15 mg | Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score | Day 28 | 67.34 scores on a scale | Standard Deviation 21.98 |
| RP5063 15 mg | Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline | 87.57 scores on a scale | Standard Deviation 13.3 |
| RP5063 30 mg | Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline | 88.74 scores on a scale | Standard Deviation 13.37 |
| RP5063 30 mg | Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score | Day 28 | 73.32 scores on a scale | Standard Deviation 20.24 |
| RP5063 50 mg | Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline | 85.88 scores on a scale | Standard Deviation 14.86 |
| RP5063 50 mg | Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score | Day 28 | 66.67 scores on a scale | Standard Deviation 19.66 |
| Aripiprazole 15 mg | Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score | Day 28 | 82.37 scores on a scale | Standard Deviation 22.13 |
| Aripiprazole 15 mg | Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline | 91.68 scores on a scale | Standard Deviation 16.1 |
| Placebo | Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score | Day 28 | 78.43 scores on a scale | Standard Deviation 24.14 |
| Placebo | Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline | 89.84 scores on a scale | Standard Deviation 15.6 |
Secondary
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S)
Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. Scores range from 1 (not ill at all) to 7 (among the most extremely ill). A reduction in score indicates an improvement in the subject's condition.
Time frame: Baseline to Day 28
Population: The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RP5063 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) | Baseline | 4.79 scores on a scale | Standard Deviation 0.56 |
| RP5063 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) | Day 28 | 3.48 scores on a scale | Standard Deviation 1.22 |
| RP5063 30 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) | Baseline | 4.81 scores on a scale | Standard Deviation 0.77 |
| RP5063 30 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) | Day 28 | 3.93 scores on a scale | Standard Deviation 1.24 |
| RP5063 50 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) | Baseline | 4.75 scores on a scale | Standard Deviation 0.71 |
| RP5063 50 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) | Day 28 | 3.54 scores on a scale | Standard Deviation 1.05 |
| Aripiprazole 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) | Day 28 | 4.53 scores on a scale | Standard Deviation 1.02 |
| Aripiprazole 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) | Baseline | 4.84 scores on a scale | Standard Deviation 0.6 |
| Placebo | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) | Baseline | 4.76 scores on a scale | Standard Deviation 0.55 |
| Placebo | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) | Day 28 | 4.05 scores on a scale | Standard Deviation 1.27 |
Secondary
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale
The General Psychopathology Scale consists of 16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). The General Psychopathology score is obtained by adding the ratings of each item in the scale, with results ranging from 16 to 112. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.
Time frame: Baseline to Day 28
Population: The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RP5063 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale | Baseline | 40.98 scores on a scale | Standard Deviation 7.3 |
| RP5063 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale | Day 28 | 32.55 scores on a scale | Standard Deviation 11.26 |
| RP5063 30 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale | Day 28 | 35.35 scores on a scale | Standard Deviation 10.12 |
| RP5063 30 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale | Baseline | 42.07 scores on a scale | Standard Deviation 7.08 |
| RP5063 50 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale | Baseline | 40.82 scores on a scale | Standard Deviation 7.61 |
| RP5063 50 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale | Day 28 | 32.23 scores on a scale | Standard Deviation 9.79 |
| Aripiprazole 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale | Day 28 | 39.42 scores on a scale | Standard Deviation 11.25 |
| Aripiprazole 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale | Baseline | 43.74 scores on a scale | Standard Deviation 9.41 |
| Placebo | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale | Baseline | 43.05 scores on a scale | Standard Deviation 8.36 |
| Placebo | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale | Day 28 | 37.92 scores on a scale | Standard Deviation 13.03 |
Secondary
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale
The Negative Scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking) and is calculated by adding the negative subscale item scores to obtain results ranging from 7 to 49. Minimum score is 7, maximum score is 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.
Time frame: Baseline to Day 28
Population: The ITT population is comprised of participants who had receiving at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RP5063 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale | Baseline | 21.80 scores on a scale | Standard Deviation 5.63 |
| RP5063 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale | Day 28 | 16.96 scores on a scale | Standard Deviation 5.11 |
| RP5063 30 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale | Day 28 | 19.21 scores on a scale | Standard Deviation 5.92 |
| RP5063 30 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale | Baseline | 22.89 scores on a scale | Standard Deviation 5.25 |
| RP5063 50 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale | Day 28 | 17.72 scores on a scale | Standard Deviation 5.89 |
| RP5063 50 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale | Baseline | 21.37 scores on a scale | Standard Deviation 5.91 |
| Aripiprazole 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale | Day 28 | 19.47 scores on a scale | Standard Deviation 5.16 |
| Aripiprazole 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale | Baseline | 22.53 scores on a scale | Standard Deviation 4.38 |
| Placebo | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale | Day 28 | 20.57 scores on a scale | Standard Deviation 6.64 |
| Placebo | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale | Baseline | 22.24 scores on a scale | Standard Deviation 6.34 |
Secondary
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale
The Positive Scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility) and is calculated by adding the subscale item scores to obtain results ranging from 7 to 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.
Time frame: Baseline to Day 28
Population: The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RP5063 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale | Day 28 | 17.82 scores on a scale | Standard Deviation 7.95 |
| RP5063 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale | Baseline | 24.79 scores on a scale | Standard Deviation 4.21 |
| RP5063 30 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale | Baseline | 23.77 scores on a scale | Standard Deviation 4.66 |
| RP5063 30 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale | Day 28 | 18.75 scores on a scale | Standard Deviation 7.27 |
| RP5063 50 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale | Day 28 | 16.72 scores on a scale | Standard Deviation 6.66 |
| RP5063 50 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale | Baseline | 23.68 scores on a scale | Standard Deviation 4.73 |
| Aripiprazole 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale | Baseline | 25.42 scores on a scale | Standard Deviation 6.77 |
| Aripiprazole 15 mg | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale | Day 28 | 23.47 scores on a scale | Standard Deviation 7.88 |
| Placebo | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale | Day 28 | 19.95 scores on a scale | Standard Deviation 6.84 |
| Placebo | Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale | Baseline | 24.54 scores on a scale | Standard Deviation 3.78 |