Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorder
Conditions
Brief summary
The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.
Interventions
DRUGolanzapine
10-20 milligrams (mg), oral, daily, 10 weeks.
DRUGrisperidone
2-6 mg, oral, daily, for 10 weeks.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients must demonstrate acute psychopathologic severity criteria and be at least moderately ill. * Patients must have experienced an exacerbation of their illness within the previous 2 weeks. * Patients in whom a switch to another antipsychotic medication is acutely indicated.
Exclusion criteria
* Patients who are deemed nonresponsive to risperidone or olanzapine. * Patients who have been hospitalized for greater than 2 weeks immediately prior to Visit 1. * Patients having received olanzapine or risperidone in the past 30 days. * Treatment with clozapine within 1 year prior to Visit 1. * Diagnosis of substance-induced psychosis by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria within 7 days of Visit 1 (or at any time during the study), or confirmed on clinical grounds within 72 hours subsequent to Visit 1 (or at any time during the study). * A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | Weeks 0, 3, 4, 6, 8, 12 | Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients | Weeks 2, 3, 4, 6, 8, 12 | Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - double-blind baseline (Week 2). |
| The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | Week 0 to Week 12 | The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone. |
| The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | Week 0 to Week 12 | The number of not early onset participants who experienced a 20% or greater reduction in PANSS Total Score at any time during the 12 weeks of combined Study Period II and Study Period III. |
| Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | Week 0 to Week 12 | 'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation. |
| Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | Week 2 to Week 12 | 'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation. |
| Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups | Week 2 to Week 12 | Psychiatric Hospitalizations were measured by the Modified Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ) from which it could be determined the number of patients with a psychiatric episode that required an overnight stay in a hospital. |
| Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index | Week 2 to Week 12 | Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline. |
| Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | Week 2 to Week 12 | Number of participants who experienced abnormal fasting laboratory values at any time during Study Period III. Laboratory reference ranges are dependent on the patient's gender, origin, and age. |
| Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure | Week 2 and Week 12 | Change from Study Period III baseline to endpoint in standing mean arterial pressure. Change = Endpoint minus baseline. |
| Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score | Week 2 to Week 12 | Evaluates akathisia associated with use of antipsychotic medications, includes objective and subjective component plus global impression rating for overall disorder. Components rated on scale of 0 to 3 for objective and subjective items and 0 to 5 for global clinical assessment, for total score of 0 (absence of akathisia) to 11 (severe akathisia). |
| Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score | Week 2 to Week 12 | A 12-item instrument assesses observed abnormal movements in different parts of body. Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. |
| Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate | Week 2 and Week 12 | Changes from Study Period III baseline to endpoint in sitting pulse rate. Change = Endpoint minus baseline. |
| Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure | Week 2 and Week 12 | Change from Study Period III baseline to endpoint in standing blood pressure. Change = Endpoint minus baseline. |
| Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate | Week 2 and Week 12 | Change from Study Period III baseline to endpoint in standing pulse rate. Change = Endpoint minus baseline. |
| Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure | Week 2 and Week 12 | Change from Study Period III baseline to endpoint in standing systolic blood pressure. Change = Endpoint minus baseline. |
| Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight | Week 2 and Week 12 | Change from Study Period III baseline to endpoint in body weight. Change = Endpoint minus baseline. |
| Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale | Week 2 to Week 12 | Measures neuroleptic-induced parkinsonism. Total score consists of the sum of 10 items: 7 items (items 1, 3, 4, 7, 8, 9, 10) rated on a 4-point severity scale where 0=normal and 4=extreme, and 3 items (items 2, 5, 6) rated on a 2-point severity scale where 0=normal and 2=definitely abnormal/present. The total score ranges from 0 to 34. |
Countries
Argentina, Russia, United States
Participant flow
Pre-assignment details
Study Period I was the screening period prior to enrollment. Study Period II was a 2-week open-label lead-in period of risperidone 2-6mg/day, at which time determination of early onset status was determined. Study Period III was a 10-week, double-blind therapy period.
Participants by arm
| Arm | Count |
|---|---|
| NEO-OLZ Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks | 186 |
| NEO-RIS Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks | 192 |
| EO-RIS Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks | 144 |
| Total | 522 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Study Period II | Adverse Event | 0 | 0 | 0 | 16 |
| Study Period II | Entry Criteria Not Met | 0 | 0 | 0 | 6 |
| Study Period II | Lack of Efficacy | 0 | 0 | 0 | 7 |
| Study Period II | Lost to Follow-up | 0 | 0 | 0 | 35 |
| Study Period II | Parent/Caregiver Decision | 0 | 0 | 0 | 1 |
| Study Period II | Physician Decision | 0 | 0 | 0 | 13 |
| Study Period II | Protocol Violation | 0 | 0 | 0 | 6 |
| Study Period II | Sponsor Decision | 0 | 0 | 0 | 2 |
| Study Period II | Withdrawal by Subject | 0 | 0 | 0 | 20 |
| Study Period III | Adverse Event | 9 | 10 | 8 | 0 |
| Study Period III | Clinical Relapse | 1 | 0 | 0 | 0 |
| Study Period III | Entry Criteria Not Met | 4 | 1 | 3 | 0 |
| Study Period III | Lack of Efficacy | 4 | 4 | 2 | 0 |
| Study Period III | Lost to Follow-up | 14 | 16 | 14 | 0 |
| Study Period III | Parent/Caregiver Decision | 0 | 0 | 2 | 0 |
| Study Period III | Physician Decision | 6 | 5 | 0 | 0 |
| Study Period III | Protocol Violation | 3 | 8 | 2 | 0 |
| Study Period III | Sponsor Decision | 1 | 0 | 1 | 0 |
| Study Period III | Withdrawal by Subject | 18 | 14 | 12 | 0 |
Baseline characteristics
| Characteristic | NEO-OLZ | Total | EO-RIS | NEO-RIS |
|---|---|---|---|---|
| Abnormal Involuntary Movement Scale - Non-Global Total Score | 0.67 units on a scale STANDARD_DEVIATION 1.82 | 0.54 units on a scale STANDARD_DEVIATION 1.58 | 0.44 units on a scale STANDARD_DEVIATION 1.38 | 0.49 units on a scale STANDARD_DEVIATION 1.48 |
| Age Continuous | 41.84 years STANDARD_DEVIATION 10.92 | 41.85 years STANDARD_DEVIATION 11.04 | 41.83 years STANDARD_DEVIATION 10.88 | 41.87 years STANDARD_DEVIATION 11.34 |
| Barnes Akathisia Rating Scale Total Score | 0.80 units on a scale STANDARD_DEVIATION 1.81 | 0.78 units on a scale STANDARD_DEVIATION 1.83 | 0.54 units on a scale STANDARD_DEVIATION 1.64 | 0.95 units on a scale STANDARD_DEVIATION 1.97 |
| Diagnosis Schizoaffective Bipolar Disorder | 31 participants | 77 participants | 21 participants | 25 participants |
| Diagnosis Schizoaffective Depression | 15 participants | 47 participants | 9 participants | 23 participants |
| Diagnosis Schizophrenia/Schizophreniform Disorder | 140 participants | 398 participants | 114 participants | 144 participants |
| Modified Simpson-Angus Scale | 0.12 units on a scale STANDARD_DEVIATION 0.29 | 0.13 units on a scale STANDARD_DEVIATION 0.5 | 0.13 units on a scale STANDARD_DEVIATION 0.82 | 0.14 units on a scale STANDARD_DEVIATION 0.29 |
| Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | 13.52 units on a scale STANDARD_DEVIATION 7.98 | 11.42 units on a scale STANDARD_DEVIATION 8.09 | 7.29 units on a scale STANDARD_DEVIATION 6.07 | 12.49 units on a scale STANDARD_DEVIATION 8.44 |
| Positive and Negative Syndrome Scale (PANSS) - Negative Subscale | 21.18 units on a scale STANDARD_DEVIATION 4.96 | 19.62 units on a scale STANDARD_DEVIATION 5.36 | 15.83 units on a scale STANDARD_DEVIATION 3.9 | 20.94 units on a scale STANDARD_DEVIATION 5.3 |
| Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | 21.50 units on a scale STANDARD_DEVIATION 4.49 | 19.61 units on a scale STANDARD_DEVIATION 5.13 | 15.37 units on a scale STANDARD_DEVIATION 3.97 | 20.95 units on a scale STANDARD_DEVIATION 4.65 |
| Positive and Negative Syndrome Scale (PANSS) - Total Score | 84.91 units on a scale STANDARD_DEVIATION 13.81 | 78.21 units on a scale STANDARD_DEVIATION 17.24 | 61.67 units on a scale STANDARD_DEVIATION 12.85 | 84.05 units on a scale STANDARD_DEVIATION 14.81 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 4 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 3 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 88 participants | 234 participants | 54 participants | 92 participants |
| Race/Ethnicity, Customized Hispanic | 14 participants | 47 participants | 15 participants | 18 participants |
| Race/Ethnicity, Customized White | 80 participants | 234 participants | 74 participants | 80 participants |
| Region of Enrollment Argentina | 4 participants | 18 participants | 9 participants | 5 participants |
| Region of Enrollment Russian Federation | 9 participants | 25 participants | 5 participants | 11 participants |
| Region of Enrollment United States | 173 participants | 479 participants | 130 participants | 176 participants |
| Sex: Female, Male Female | 66 Participants | 200 Participants | 58 Participants | 76 Participants |
| Sex: Female, Male Male | 120 Participants | 322 Participants | 86 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 97 / — | 100 / — | 83 / — |
| serious Total, serious adverse events | 19 / 186 | 12 / 192 | 14 / 144 |
Outcome results
Primary
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients
Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).
Time frame: Weeks 0, 3, 4, 6, 8, 12
Population: Intention to treat for patients with both baseline and any postbaseline assessment
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| NEO-RIS | Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | Change from Week 0 to Week 4 | -14.81 units on a scale | Standard Error 1.16 |
| NEO-RIS | Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | Change from Week 0 to Week 8 | -18.10 units on a scale | Standard Error 1.31 |
| NEO-RIS | Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | Change from Week 0 to Week 6 | -16.23 units on a scale | Standard Error 1.26 |
| NEO-RIS | Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | Change from Week 0 to Week 12 | -18.62 units on a scale | Standard Error 1.38 |
| NEO-RIS | Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | Change from Week 0 to Week 3 | -11.90 units on a scale | Standard Error 1.15 |
| EO-RIS | Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | Change from Week 0 to Week 12 | -35.09 units on a scale | Standard Error 1.5 |
| EO-RIS | Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | Change from Week 0 to Week 3 | -30.80 units on a scale | Standard Error 1.23 |
| EO-RIS | Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | Change from Week 0 to Week 4 | -32.53 units on a scale | Standard Error 1.24 |
| EO-RIS | Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | Change from Week 0 to Week 6 | -32.90 units on a scale | Standard Error 1.36 |
| EO-RIS | Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | Change from Week 0 to Week 8 | -34.10 units on a scale | Standard Error 1.43 |
p-value: <0.001Mixed Effects Model Repeated Measures
Secondary
Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients
Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - double-blind baseline (Week 2).
Time frame: Weeks 2, 3, 4, 6, 8, 12
Population: Intention to treat patients with both baseline and postbaseline assessment
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| NEO-RIS | Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients | Change from Week 2 to Week 4 | -9.82 units on a scale | Standard Error 0.86 |
| NEO-RIS | Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients | Change from Week 2 to Week 8 | -13.13 units on a scale | Standard Error 1 |
| NEO-RIS | Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients | Change from Week 2 to Week 6 | -11.25 units on a scale | Standard Error 0.98 |
| NEO-RIS | Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients | Change from Week 2 to Week 12 | -13.53 units on a scale | Standard Error 1.13 |
| NEO-RIS | Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients | Change from Week 2 to Week 3 | -6.94 units on a scale | Standard Error 0.82 |
| EO-RIS | Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients | Change from Week 2 to Week 12 | -17.02 units on a scale | Standard Error 1.16 |
| EO-RIS | Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients | Change from Week 2 to Week 3 | -5.85 units on a scale | Standard Error 0.84 |
| EO-RIS | Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients | Change from Week 2 to Week 4 | -9.67 units on a scale | Standard Error 0.88 |
| EO-RIS | Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients | Change from Week 2 to Week 6 | -13.06 units on a scale | Standard Error 1.02 |
| EO-RIS | Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients | Change from Week 2 to Week 8 | -14.73 units on a scale | Standard Error 1.04 |
p-value: 0.266Mixed-Effects Model Repeated-Measures
p-value: 0.884Mixed-Effects Model Repeated-Measures
p-value: 0.151Mixed-Effects Model Repeated-Measures
p-value: 0.216Mixed-Effects Model Repeated-Measures
p-value: 0.02Mixed-Effects Model Repeated-Measures
Secondary
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score
A 12-item instrument assesses observed abnormal movements in different parts of body. Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42.
Time frame: Week 2 to Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NEO-RIS | Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score | -0.38 units on a scale | Standard Deviation 1.73 |
| EO-RIS | Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score | 0.11 units on a scale | Standard Deviation 2.07 |
| EO-RIS | Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score | -0.16 units on a scale | Standard Deviation 1.27 |
p-value: 0.266ANOVA
p-value: 0.015ANOVA
Secondary
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score
Evaluates akathisia associated with use of antipsychotic medications, includes objective and subjective component plus global impression rating for overall disorder. Components rated on scale of 0 to 3 for objective and subjective items and 0 to 5 for global clinical assessment, for total score of 0 (absence of akathisia) to 11 (severe akathisia).
Time frame: Week 2 to Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NEO-RIS | Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score | -0.31 units on a scale | Standard Deviation 1.99 |
| EO-RIS | Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score | -0.13 units on a scale | Standard Deviation 2.04 |
| EO-RIS | Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score | -0.24 units on a scale | Standard Deviation 1.38 |
p-value: 0.998ANOVA
p-value: 0.505ANOVA
Secondary
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale
Measures neuroleptic-induced parkinsonism. Total score consists of the sum of 10 items: 7 items (items 1, 3, 4, 7, 8, 9, 10) rated on a 4-point severity scale where 0=normal and 4=extreme, and 3 items (items 2, 5, 6) rated on a 2-point severity scale where 0=normal and 2=definitely abnormal/present. The total score ranges from 0 to 34.
Time frame: Week 2 to Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NEO-RIS | Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale | -0.06 units on a scale | Standard Deviation 0.27 |
| EO-RIS | Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale | -0.03 units on a scale | Standard Deviation 0.26 |
| EO-RIS | Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale | -0.02 units on a scale | Standard Deviation 0.16 |
p-value: 0.355ANOVA
p-value: 0.244ANOVA
Secondary
Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission
'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.
Time frame: Week 0 to Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NEO-RIS | Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | >=50% Reduction - Yes | 67 participants |
| NEO-RIS | Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | >=50% Reduction - No | 122 participants |
| EO-RIS | Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | >=50% Reduction - No | 51 participants |
| EO-RIS | Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | >=50% Reduction - Yes | 87 participants |
p-value: <0.001Fisher Exact
Secondary
Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission
'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.
Time frame: Week 2 to Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NEO-RIS | Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | >=50% Reduction - Yes | 67 participants |
| NEO-RIS | Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | >=50% Reduction - No | 122 participants |
| EO-RIS | Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | >=50% Reduction - Yes | 67 participants |
| EO-RIS | Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | >=50% Reduction - No | 112 participants |
p-value: 0.745Fisher Exact
Secondary
Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups
Psychiatric Hospitalizations were measured by the Modified Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ) from which it could be determined the number of patients with a psychiatric episode that required an overnight stay in a hospital.
Time frame: Week 2 to Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NEO-RIS | Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups | Required overnight stay in hospital: Yes | 9 participants |
| NEO-RIS | Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups | Required overnight stay in hospital: No | 175 participants |
| EO-RIS | Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups | Required overnight stay in hospital: Yes | 10 participants |
| EO-RIS | Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups | Required overnight stay in hospital: No | 127 participants |
p-value: 0.474Fisher Exact
Secondary
Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants
Number of participants who experienced abnormal fasting laboratory values at any time during Study Period III. Laboratory reference ranges are dependent on the patient's gender, origin, and age.
Time frame: Week 2 to Week 12
Population: Total number of patients with the lab test at baseline and post-baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NEO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | Low total bilirubin | 5 participants |
| NEO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | High creatine phosphokinase | 6 participants |
| NEO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | High creatinine | 2 participants |
| NEO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | High hemoglobin A1c | 6 participants |
| NEO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | Low sodium | 4 participants |
| NEO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | High prolactin | 7 participants |
| EO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | High prolactin | 8 participants |
| EO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | Low total bilirubin | 3 participants |
| EO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | High hemoglobin A1c | 7 participants |
| EO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | Low sodium | 4 participants |
| EO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | High creatine phosphokinase | 1 participants |
| EO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | High creatinine | 4 participants |
| EO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | High creatine phosphokinase | 5 participants |
| EO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | High creatinine | 3 participants |
| EO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | High prolactin | 7 participants |
| EO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | High hemoglobin A1c | 2 participants |
| EO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | Low total bilirubin | 2 participants |
| EO-RIS | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | Low sodium | 4 participants |
p-value: >0.05Fisher Exact
Secondary
The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score
The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone.
Time frame: Week 0 to Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NEO-RIS | The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | >=20% Reduction - No | 95 participants |
| NEO-RIS | The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | >=20% Reduction - Yes | 94 participants |
| EO-RIS | The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | >=20% Reduction - Yes | 119 participants |
| EO-RIS | The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | >=20% Reduction - No | 19 participants |
p-value: <0.001Fisher Exact
Secondary
The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score
The number of not early onset participants who experienced a 20% or greater reduction in PANSS Total Score at any time during the 12 weeks of combined Study Period II and Study Period III.
Time frame: Week 0 to Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NEO-RIS | The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | >=20% Reduction - Yes | 94 participants |
| NEO-RIS | The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | >=20% Reduction - No | 95 participants |
| EO-RIS | The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | >=20% Reduction - Yes | 94 participants |
| EO-RIS | The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | >=20% Reduction - No | 85 participants |
p-value: 0.604Fisher Exact
Secondary
Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure
Change from Study Period III baseline to endpoint in standing blood pressure. Change = Endpoint minus baseline.
Time frame: Week 2 and Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5- visit 9) visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEO-RIS | Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure | Baseline | 78.69 mm Hg | Standard Deviation 10.01 |
| NEO-RIS | Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure | Change from Baseline | 1.01 mm Hg | Standard Deviation 10.79 |
| EO-RIS | Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure | Baseline | 78.57 mm Hg | Standard Deviation 10.68 |
| EO-RIS | Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure | Change from Baseline | -0.20 mm Hg | Standard Deviation 9.96 |
| EO-RIS | Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure | Baseline | 80.29 mm Hg | Standard Deviation 10.65 |
| EO-RIS | Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure | Change from Baseline | -1.73 mm Hg | Standard Deviation 8.92 |
p-value: 0.254ANOVA
p-value: 0.299ANOVA
Secondary
Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure
Change from Study Period III baseline to endpoint in standing mean arterial pressure. Change = Endpoint minus baseline.
Time frame: Week 2 and Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEO-RIS | Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure | Baseline | 93.53 mm Hg | Standard Deviation 10.24 |
| NEO-RIS | Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure | Change from Baseline | 0.68 mm Hg | Standard Deviation 9.58 |
| EO-RIS | Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure | Baseline | 93.81 mm Hg | Standard Deviation 11.42 |
| EO-RIS | Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure | Change from Baseline | -0.58 mm Hg | Standard Deviation 10.12 |
| EO-RIS | Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure | Baseline | 94.60 mm Hg | Standard Deviation 10.67 |
| EO-RIS | Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure | Change from Baseline | -1.94 mm Hg | Standard Deviation 8.13 |
p-value: 0.291ANOVA
p-value: 0.259ANOVA
Secondary
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index
Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline.
Time frame: Week 2 to Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index | Baseline | 29.97 kilogram per square meter | Standard Deviation 8.03 |
| NEO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index | Change from Baseline | 0.63 kilogram per square meter | Standard Deviation 1.38 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index | Baseline | 31.05 kilogram per square meter | Standard Deviation 8.04 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index | Change from Baseline | 0.43 kilogram per square meter | Standard Deviation 1.45 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index | Baseline | 31.13 kilogram per square meter | Standard Deviation 8.77 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index | Change from Baseline | 0.10 kilogram per square meter | Standard Deviation 1.19 |
p-value: 0.034ANOVA
p-value: 0.125ANOVA
Secondary
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight
Change from Study Period III baseline to endpoint in body weight. Change = Endpoint minus baseline.
Time frame: Week 2 and Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight | Baseline | 88.28 kilograms | Standard Deviation 23.52 |
| NEO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight | Change from Baseline | 1.85 kilograms | Standard Deviation 3.97 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight | Change from Baseline | 1.29 kilograms | Standard Deviation 4.25 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight | Baseline | 90.25 kilograms | Standard Deviation 22.81 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight | Baseline | 90.67 kilograms | Standard Deviation 25.39 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight | Change from Baseline | 0.30 kilograms | Standard Deviation 3.26 |
p-value: 0.026ANOVA
p-value: 0.143ANOVA
Secondary
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate
Changes from Study Period III baseline to endpoint in sitting pulse rate. Change = Endpoint minus baseline.
Time frame: Week 2 and Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate | Baseline | 80.49 beats per minute | Standard Deviation 11.57 |
| NEO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate | Change from Baseline | -0.98 beats per minute | Standard Deviation 11.81 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate | Baseline | 80.84 beats per minute | Standard Deviation 12.06 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate | Change from Baseline | -2.52 beats per minute | Standard Deviation 11.5 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate | Baseline | 77.90 beats per minute | Standard Deviation 11.02 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate | Change from Baseline | -0.94 beats per minute | Standard Deviation 12.82 |
p-value: 0.14ANOVA
p-value: 0.181ANOVA
Secondary
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate
Change from Study Period III baseline to endpoint in standing pulse rate. Change = Endpoint minus baseline.
Time frame: Week 2 and Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate | Baseline | 85.57 beats per minute | Standard Deviation 12.83 |
| NEO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate | Change from Baseline | -1.13 beats per minute | Standard Deviation 14.2 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate | Baseline | 85.32 beats per minute | Standard Deviation 13.54 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate | Change from Baseline | -2.05 beats per minute | Standard Deviation 13.21 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate | Baseline | 82.39 beats per minute | Standard Deviation 11.46 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate | Change from Baseline | -0.56 beats per minute | Standard Deviation 12.4 |
p-value: 0.209ANOVA
p-value: 0.411ANOVA
Secondary
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure
Change from Study Period III baseline to endpoint in standing systolic blood pressure. Change = Endpoint minus baseline.
Time frame: Week 2 and Week 12
Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure | Baseline | 123.20 mm Hg | Standard Deviation 14.02 |
| NEO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure | Change from Baseline | 0.01 mm Hg | Standard Deviation 12.9 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure | Baseline | 124.30 mm Hg | Standard Deviation 16.23 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure | Change from Baseline | -1.35 mm Hg | Standard Deviation 14.22 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure | Baseline | 123.20 mm Hg | Standard Deviation 13.63 |
| EO-RIS | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure | Change from Baseline | -2.36 mm Hg | Standard Deviation 10.78 |
p-value: 0.544ANOVA
p-value: 0.386ANOVA