| ID | Type | Description | Link |
|---|---|---|---|
| F1D-US-HGMN | Other Identifier | Eli Lilly and Company |
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The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Olanzapine for Not Early Onset response (NEO) patients |
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| 2 | Active Comparator | Risperidone for Not Early Onset response (NEO) patients |
|
| 3 | Active Comparator | Risperidone for Early Onset response (EO) patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olanzapine | Drug | 10-20 milligrams (mg), oral, daily, 10 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Weeks 0, 3, 4, 6, 8, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Little Rock | Arkansas | 72201 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22204569 | Derived | Chen L, Phillips G, Johnston J, Kinon BJ, Ascher-Svanum H, Kollack-Walker S, Succop P, Naber D. The relationship, structure and profiles of schizophrenia measurements: a post-hoc analysis of the baseline measures from a randomized clinical trial. BMC Psychiatry. 2011 Dec 28;11:203. doi: 10.1186/1471-244X-11-203. | |
| 21813073 | Derived |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | NEO-OLZ | Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks |
| FG001 | NEO-RIS | Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Period II |
|
Not provided
Not provided
Not provided
Not provided
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Not provided
| risperidone | Drug | 2-6 mg, oral, daily, for 10 weeks. |
|
| risperidone | Drug | 2-6 mg, oral, daily, 10 weeks |
|
| Weeks 2, 3, 4, 6, 8, 12 |
| 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. | Week 0 to Week 12 |
| 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. | Week 0 to Week 12 |
| 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. | Week 0 to Week 12 |
| 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. | Week 2 to Week 12 |
| 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. | Week 2 to Week 12 |
| 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. | Week 2 to Week 12 |
| 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. | Week 2 to Week 12 |
| 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. | Week 2 to Week 12 |
| 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). | Week 2 to Week 12 |
| 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. | Week 2 to Week 12 |
| 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. | Week 2 and Week 12 |
| 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. | Week 2 and Week 12 |
| 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. | Week 2 and Week 12 |
| 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. | Week 2 and Week 12 |
| 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. | Week 2 and Week 12 |
| 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. | Week 2 and Week 12 |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Escondido | California | 92025 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Garden Grove | California | 92845 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Glendale | California | 91206 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | National City | California | 91950 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Orange | California | 92868 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Diego | California | 92123 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santa Ana | California | 92701 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Washington D.C. | District of Columbia | 20016 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fort Lauderdale | Florida | 33319 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hialeah | Florida | 33016 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chicago | Illinois | 60640 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Paducah | Kentucky | 42003 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lake Charles | Louisiana | 70601 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Boston | Massachusetts | 02118 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jackson | Mississippi | 39216 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kansas City | Missouri | 64108 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Omaha | Nebraska | 68133 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Clementon | New Jersey | 08021 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cedarhurst | New York | 11516 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Olean | New York | 14760 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Staten Island | New York | 10312 | United States |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Philadelphia | Pennsylvania | 19131 | United States |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Memphis | Tennessee | 38117 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Austin | Texas | 78754 | United States |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kirkland | Washington | 98033 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Buenos Aires | C1062ABF | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Khot'kovo | 127025 | Russia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Moscow | 115522 | Russia |
| Fijal BA, Stauffer VL, Kinon BJ, Conley RR, Hoffmann VP, Witte MM, Zhao F, Houston JP. Analysis of gene variants previously associated with iloperidone response in patients with schizophrenia who are treated with risperidone. J Clin Psychiatry. 2012 Mar;73(3):367-71. doi: 10.4088/JCP.10m06507. Epub 2011 Jul 12. |
| 20812791 | Derived | Ascher-Svanum H, Nyhuis AW, Stauffer V, Kinon BJ, Faries DE, Phillips GA, Schuh K, Awad AG, Keefe R, Naber D. Reasons for discontinuation and continuation of antipsychotics in the treatment of schizophrenia from patient and clinician perspectives. Curr Med Res Opin. 2010 Oct;26(10):2403-10. doi: 10.1185/03007995.2010.515900. |
| 19890258 | Derived | Kinon BJ, Chen L, Ascher-Svanum H, Stauffer VL, Kollack-Walker S, Zhou W, Kapur S, Kane JM. Early response to antipsychotic drug therapy as a clinical marker of subsequent response in the treatment of schizophrenia. Neuropsychopharmacology. 2010 Jan;35(2):581-90. doi: 10.1038/npp.2009.164. |
| FG002 | EO-RIS | Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks |
| FG003 | Risperiodone Open-Label Lead-In | All patients completed a 2-week open-label risperidone lead-in period. This group contains all patients who started Study Period II. Risperidone: 2-6 mg, oral, daily |
| COMPLETED |
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| NOT COMPLETED |
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| Study Period III |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NEO-OLZ | Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks |
| BG001 | NEO-RIS | Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks |
| BG002 | EO-RIS | Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Diagnosis | Number | participants |
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| Abnormal Involuntary Movement Scale - 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score | Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Positive and Negative Syndrome Scale (PANSS) - Negative Subscale | Assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (ex. blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Positive and Negative Syndrome Scale (PANSS) - Total Score | Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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). | Intention to treat for patients with both baseline and any postbaseline assessment | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 0, 3, 4, 6, 8, 12 |
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| 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). | Intention to treat patients with both baseline and postbaseline assessment | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 2, 3, 4, 6, 8, 12 |
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| 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. | 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. | Posted | Number | participants | Week 0 to Week 12 |
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| 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. | 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. | Posted | Number | participants | Week 0 to Week 12 |
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| 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. | 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. | Posted | Number | participants | Week 0 to Week 12 |
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| 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. | 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. | Posted | Number | participants | Week 2 to Week 12 |
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| 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. | 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. | Posted | Number | participants | Week 2 to Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | kilogram per square meter | Week 2 to Week 12 |
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| 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. | Total number of patients with the lab test at baseline and post-baseline. | Posted | Number | participants | Week 2 to Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Week 2 to Week 12 |
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| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Week 2 to Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Week 2 to Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | beats per minute | Week 2 and Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | mm Hg | Week 2 and Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | mm Hg | Week 2 and Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | beats per minute | Week 2 and Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | mm Hg | Week 2 and Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | kilograms | Week 2 and Week 12 |
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Not provided
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NEO-OLZ | Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks. | 19 | 186 | 97 | |||
| EG001 | NEO-RIS | Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks. | 12 | 192 | 100 | |||
| EG002 | EO-RIS | Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks. | 14 | 144 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA10.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA10.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA10.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA10.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA10.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA10.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Homicidal ideation | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Hostility | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Schizoaffective disorder | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA10.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA10.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA10.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA10.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA10.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA10.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA10.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA10.0 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA10.0 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA10.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA10.0 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA10.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA10.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA10.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Bruxism | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA10.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Withdrawal by Subject |
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| Adverse Event |
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| Protocol Violation |
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| Physician Decision |
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| Entry Criteria Not Met |
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| Lack of Efficacy |
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| Parent/Caregiver Decision |
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| Sponsor Decision |
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| Clinical Relapse |
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| Male |
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| Asian |
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| Black or African American |
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| White |
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| Hispanic |
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| Argentina |
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| Russian Federation |
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| Schizoaffective Bipolar Disorder |
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| Schizoaffective Depression |
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| Change from Week 0 to Week 6 |
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| Change from Week 0 to Week 12 |
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