Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the clinical outcome of two switching strategies to iloperidone treatment in adult subjects with schizophrenia who require a change in their current antipsychotic treatment of risperidone, olanzapine, or aripiprazole due to suboptimal efficacy and/or safety/tolerability reasons.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iloperidone gradual switch | Experimental | Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week. On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks. |
|
| iloperidone immediate switch | Experimental | Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately. On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iloperidone | Drug | Iloperidone tablets supplied at doses of 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg to achieve a target dose of 12-24 mg/day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12 | The I-CGI-C at Week 12 was the overall impression of medically qualified raters using three separate Clinical Global Impression of Change scales: efficacy (E-CGI-C); safety and tolerability (ST-CGI-S); and overall severity (I-CGI-S) combined for a total score. The I-CGI-C scale ranged from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 12 | The TSQM consisted of 14 questions about the patient's satisfaction with the drug in 4 domains: Effectiveness [3 questions scored as 1(extremely dissatisfied) to 7(extremely satisfied)], Side Effects [question 4 scored as 0(no) or 1(yes);question 5 scored as 1(extremely bothersome) to 5(not at all bothersome);questions 6 - 8 scored as 1(a great deal) to 5(not at all)], Convenience [questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy);question 11 scored as 1(extremely inconvenient) to 5 (extremely convenient)] and Global Satisfaction [question 12 scored as 1(not at all confident) to 7(extremely confident);question 13 scored as 1(not at all certain) to 5(extremely certain);question 14 scored as 1(extremely dissatisfied) to 5(extremely satisfied)]. The scores of each of the domains were added together and an algorithm used to create a score of 0 to 100. Higher scores for each domain indicate a better outcome. A positive change from baseline indicates improvement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marla Hochfeld, MD, MD | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Psychiatry Pharmaceutical Studies, Inc. | Birmingham | Alabama | 35226 | United States | ||
| Comprehensive Neuroscience |
500 participants taking antipsychotic drugs: 175 participants in the risperidone cohort, 155 participants in the olanzapine cohort and 170 participants in the aripiprazole cohort were randomized and received study drug in one of two iloperidone treatment arms: gradual switch or immediate switch. 1 randomized participant did not receive study drug.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Iloperidone Gradual Switch | Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week. On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline, Week 12 |
| Number of Participants With Adverse Events, Serious Adverse Events or Death | Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards. Additional information about adverse events can be found in the Adverse Event section. | 12 Weeks |
| Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at Week 12 | Medically qualified raters use the E-CGI-S scale at Baseline and Week 12 to assess the effectiveness of treatment by examining changes in positive symptoms [hallucinations (false perceptions), delusions (false beliefs), paranoia (unfounded distrust), conceptual disorganization (loosening of associations), or hostility], negative symptoms [apathy (lack of interest), avolition (lack of motivation), alogia (poverty of speech), and anhedonia (absence of pleasure)] and cognitive symptoms [concentration difficulties, difficulties with executive function (integrative reasoning), and illogical thinking] in the previous 7 days on a scale of 1 to 7 (1=normal, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill or 7=among the most extremely ill). A negative change from baseline indicates improvement. | Baseline, Week 12 |
| Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at Week 12 | Medically qualified raters used the ST-CGI-S at Baseline and Week 12 to evaluate safety and tolerability in the previous 7 days on a scale of 1 to 7 (1=Normal-no symptoms, 2=borderline severity, 3=mild impairment, 4=moderate, 5=marked, 6=severe, 7=among the most severe.) A negative change from baseline indicates improvement. | Baseline, Week 12 |
| Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at Week 12 | I-CGI-S incorporated the overall, combined impression of illness severity based upon the E-CGI-S and ST-CGI-S. Medically qualified raters evaluated the patient's illness in the previous 7 days at Baseline and Week 12 on a scale of 1 to 7 (1=normal not at all ill, 2=borderline mental illness or impairment, 3=mildly ill or impaired, 4=moderately ill or impaired, 5=marked ill or impaired, 6= severely ill or impaired or 7=among the most extremely ill patients. A negative change from baseline indicates improvement. | Baseline, Week 12 |
| Cerritos |
| California |
| 90703 |
| United States |
| ATP Clinical Research Center, Inc. | Costa Mesa | California | 92626 | United States |
| Collaborative Neuroscience Network | Garden Grove | California | 92845 | United States |
| Apostle Clinical Trials, Inc. | Long Beach | California | 90813 | United States |
| Pacific Health Systems | National City | California | 91950 | United States |
| Pacific Research Partners | Oakland | California | 94612 | United States |
| Excell Research, Inc. | Oceanside | California | 92056 | United States |
| University of California, Irvine | Orange | California | 92868 | United States |
| CNRI San Diego | San Diego | California | 92102 | United States |
| Affiliated Research Institute | San Diego | California | 92108 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92108 | United States |
| Neuropsychiatric Research Center of Orange County | Santa Ana | California | 92701 | United States |
| Viking Clinical Research | Temecula | California | 92591 | United States |
| Collaborative Neuroscience | Torrance | California | 90502 | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06052 | United States |
| Comprenhensive Neuroscience | Washington D.C. | District of Columbia | 20016 | United States |
| Amit K. Vijapura MD & Associates | Jacksonville | Florida | 32256 | United States |
| Scientific Clinical Research | North Miami | Florida | 33161 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| Comprehensive Neuroscience | Atlanta | Georgia | 30328 | United States |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | United States |
| Carman Research | Smyrna | Georgia | 30080 | United States |
| Institute for Behavioral Medicine | Smyrna | Georgia | 30080 | United States |
| Alexian Brothers Center for Mental Health | Arlington Heights | Illinois | 60005 | United States |
| Rush University Medical Center, Treatment Research Center | Chicago | Illinois | 60612 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| AMR - Baber Research, Inc. | Naperville | Illinois | 60563 | United States |
| Midwest Center for Neurobehavioral Medicine | Oakbrook Terrace | Illinois | 60181 | United States |
| Louisiana Clinical Research | Shreveport | Louisiana | 71115 | United States |
| Neurobehavioral Medicine Group, Clinical Trials Division | Bloomfield Hills | Michigan | 48302 | United States |
| Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | 48307 | United States |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63301 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| CRI World Wide Clinical Research Company | Willingboro | New Jersey | 08046 | United States |
| Albuquerque Neuroscience | Albuquerque | New Mexico | 87109 | United States |
| Neurobehavioral Research | Cedarhurst | New York | 11516 | United States |
| Comprehensive Neuroscience | Fresh Meadows | New York | 11366 | United States |
| Division of Psychiatry Research - Zucker Hills Hospital | Glen Oaks | New York | 11004 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Behavioral Medical Research | Staten Island | New York | 10305 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| North Coast Clinical Trials | Beachwood | Ohio | 44122 | United States |
| Neurobehavioral Clinical Research | Canton | Ohio | 44718 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| SP Research, PLLC | Oklahoma City | Oklahoma | 73112 | United States |
| Belmont Center for Comprehensive Treatment | Philadelphia | Pennsylvania | 19131 | United States |
| CRI Worldwide, LLC - Kirkbride Division | Philadelphia | Pennsylvania | 19139 | United States |
| Carolina Clinical Trials | Charleston | South Carolina | 29407 | United States |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | United States |
| KRK Medical Research | Dallas | Texas | 75230 | United States |
| FutureSearch Trials | Dallas | Texas | 75231 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| Bayou City Research Limited | Houston | Texas | 77007 | United States |
| Claghorn-Lesem Research Clinic, Inc | Houston | Texas | 77008 | United States |
| Mary Ann Knesevich, MD, PA | Irving | Texas | 75062 | United States |
| InSite Clinical Research | Plano | Texas | 75074 | United States |
| Frontier Institute | Spokane | Washington | 99204 | United States |
| FG001 | Iloperidone Immediate Switch | Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately. On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks. |
| Safety Population: Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Iloperidone Gradual Switch | Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week. On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks. |
| BG001 | Iloperidone Immediate Switch | Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately. On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Baseline Measures are based on the Safety Population that includes all randomized participants who received study drug. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12 | The I-CGI-C at Week 12 was the overall impression of medically qualified raters using three separate Clinical Global Impression of Change scales: efficacy (E-CGI-C); safety and tolerability (ST-CGI-S); and overall severity (I-CGI-S) combined for a total score. The I-CGI-C scale ranged from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change. | Participants from the Full Analysis Set (three cohorts combined: risperidone, olanzapine or aripiprazole) with data available for analyses. | Posted | Mean | Standard Deviation | Score on a scale | Week 12 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 12 | The TSQM consisted of 14 questions about the patient's satisfaction with the drug in 4 domains: Effectiveness [3 questions scored as 1(extremely dissatisfied) to 7(extremely satisfied)], Side Effects [question 4 scored as 0(no) or 1(yes);question 5 scored as 1(extremely bothersome) to 5(not at all bothersome);questions 6 - 8 scored as 1(a great deal) to 5(not at all)], Convenience [questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy);question 11 scored as 1(extremely inconvenient) to 5 (extremely convenient)] and Global Satisfaction [question 12 scored as 1(not at all confident) to 7(extremely confident);question 13 scored as 1(not at all certain) to 5(extremely certain);question 14 scored as 1(extremely dissatisfied) to 5(extremely satisfied)]. The scores of each of the domains were added together and an algorithm used to create a score of 0 to 100. Higher scores for each domain indicate a better outcome. A positive change from baseline indicates improvement. | Participants from the Full Analysis Set with data available for analyses. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events, Serious Adverse Events or Death | Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards. Additional information about adverse events can be found in the Adverse Event section. | Participants from the Safety Analysis Set- all randomized participants who received study drug (three cohorts combined: risperidone, olanzapine or aripiprazole) with data available for analyses. | Posted | Number | Participants | 12 Weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at Week 12 | Medically qualified raters use the E-CGI-S scale at Baseline and Week 12 to assess the effectiveness of treatment by examining changes in positive symptoms [hallucinations (false perceptions), delusions (false beliefs), paranoia (unfounded distrust), conceptual disorganization (loosening of associations), or hostility], negative symptoms [apathy (lack of interest), avolition (lack of motivation), alogia (poverty of speech), and anhedonia (absence of pleasure)] and cognitive symptoms [concentration difficulties, difficulties with executive function (integrative reasoning), and illogical thinking] in the previous 7 days on a scale of 1 to 7 (1=normal, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill or 7=among the most extremely ill). A negative change from baseline indicates improvement. | Participants from the Full Analysis Set with data available for analyses. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at Week 12 | Medically qualified raters used the ST-CGI-S at Baseline and Week 12 to evaluate safety and tolerability in the previous 7 days on a scale of 1 to 7 (1=Normal-no symptoms, 2=borderline severity, 3=mild impairment, 4=moderate, 5=marked, 6=severe, 7=among the most severe.) A negative change from baseline indicates improvement. | Participants from the Full Analysis Set with data available for analyses. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at Week 12 | I-CGI-S incorporated the overall, combined impression of illness severity based upon the E-CGI-S and ST-CGI-S. Medically qualified raters evaluated the patient's illness in the previous 7 days at Baseline and Week 12 on a scale of 1 to 7 (1=normal not at all ill, 2=borderline mental illness or impairment, 3=mildly ill or impaired, 4=moderately ill or impaired, 5=marked ill or impaired, 6= severely ill or impaired or 7=among the most extremely ill patients. A negative change from baseline indicates improvement. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12 |
|
12 weeks
Safety Set includes all randomized participants who received at least one dose of study drug.
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 | Iloperidone Gradual Switch | Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week. On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks. | 8 | 240 | 148 | 240 | ||
| EG001 | Iloperidone Immediate Switch | Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately. On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks. | 7 | 260 | 155 | 260 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Concomitant disease progression | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Social stay hospitalisation | Social circumstances | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C081732 | iloperidone |
Not provided
Not provided
Not provided
| Male |
|
| OG001 | Iloperidone Immediate Switch | Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately. On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks. |
|
|
| Iloperidone Immediate Switch |
Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately. On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks. |
|
|
| OG001 | Iloperidone Immediate Switch | Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately. On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks. |
|
|
|
|
|
|