A Phase 4 interventional study of iloperidone in Schizophrenia, sponsored by Novartis. Completed at 59 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2013-03-15.
Sponsored by Novartis · Phase 4, Interventional, and Treatment
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.
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This study's enrollment of 501 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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.
Drug: iloperidone
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.
Drug: iloperidone
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.
Also known as: Fanapt™
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.
Time frame: Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 12
| Milestone | Iloperidone Gradual Switch | Iloperidone Immediate Switch |
|---|---|---|
| Started | 241 | 260 |
| Safety population: received study drug | 240 | 260 |
| Completed | 168 | 178 |
| Not completed | 73 | 82 |
| Withdrew: Adverse event | 25 | 39 |
| Withdrew: Abnormal test procedure results | 0 | 1 |
| Withdrew: Unsatisfactory therapeutic effect | 5 | 4 |
| Withdrew: Patient withdrew consent | 14 | 11 |
| Withdrew: Lost to follow-up | 15 | 17 |
| Withdrew: Administrative problems | 1 | 1 |
| Withdrew: Protocol deviation | 12 | 9 |
| Withdrew: Randomized in error | 1 | 0 |
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.
| Score on a scale | Iloperidone Gradual Switch | Iloperidone Immediate Switch |
|---|---|---|
| Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12 | 2.826 ± 1.1244 | 2.824 ± 1.3300 |
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.
| Score on a scale | Iloperidone Gradual Switch | Iloperidone Immediate Switch |
|---|---|---|
| Change from baseline 3 cohorts combined | 14.1 ± 29.56 | 12.7 ± 27.89 |
| Change from baseline risperidone cohort (n=75,85) | 14.4 ± 27.0 | 16.6 ± 29.65 |
| Change from baseline olanzapine cohort (n=70,67) | 13.3 ± 28.17 | 9.9 ± 28.60 |
| Change from baseline aripiprazole cohort (n=69,81) | 14.8 ± 33.72 | 11.0 ± 25.12 |
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 | Iloperidone Gradual Switch | Iloperidone Immediate Switch |
|---|---|---|
| Serious Adverse Events | 8 | 7 |
| Adverse Events | 196 | 207 |
| Death | 0 | 0 |
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.
| Score on a scale | Iloperidone Gradual Switch | Iloperidone Immediate Switch |
|---|---|---|
| Change from baseline 3 cohorts combined | -0.8 ± 0.89 | -0.8 ± 0.89 |
| Change from baseline risperidone cohort (n=81,92) | -0.9 ± 0.82 | -0.9 ± 0.85 |
| Change from baseline olanzapine cohort (n=77,74) | -0.8 ± 0.96 | -0.6 ± 0.88 |
| Change from baseline aripiprazole cohort (n=77,90) | -0.8 ± 0.89 | -0.9 ± 0.92 |
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.
| Score on a scale | Iloperidone Gradual Switch | Iloperidone Immediate Switch |
|---|---|---|
| Change from baseline 3 cohorts combined | -0.9 ± 1.29 | -0.8 ± 1.45 |
| Change from baseline risperidone cohort (n=81,92) | -1.1 ± 1.27 | -0.9 ± 1.49 |
| Change from baseline olanzapine cohort (n=77,74) | -0.9 ± 1.20 | -0.9 ± 1.36 |
| Change from baseline aripiprazole cohort (n=77,90) | -0.8 ± 1.39 | -0.4 ± 1.45 |
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.
| Score on a scale | Iloperidone Gradual Switch | Iloperidone Immediate Switch |
|---|---|---|
| Change from baseline 3 cohorts combined | -0.9 ± 0.95 | -0.9 ± 0.97 |
| Change from baseline risperidone cohort (n=81,92) | -0.9 ± 0.85 | -1.0 ± 0.89 |
| Change from baseline olanzapine cohort (n=77,74) | -0.8 ± 0.96 | -0.7 ± 0.98 |
| Change from baseline aripiprazole cohort (n=77,80) | -1.0 ± 1.04 | -0.9 ± 1.04 |
Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Iloperidone Gradual Switch | — | 8/240 (3.3%) | 148/240 (61.7%) |
| Iloperidone Immediate Switch | — | 7/260 (2.7%) | 155/260 (59.6%) |
| Event | Iloperidone Gradual Switch | Iloperidone Immediate Switch |
|---|---|---|
| SchizophreniaPsychiatric disorders | 1/240 | 2/260 |
| Lower gastrointestinal haemorrhageGastrointestinal disorders | 1/240 | 0/260 |
| Concomitant disease progressionGeneral disorders | 1/240 | 0/260 |
| AppendicitisInfections and infestations | 1/240 | 0/260 |
| OverdoseInjury, poisoning and procedural complications | 1/240 | 0/260 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/240 | 0/260 |
| SyncopeNervous system disorders | 1/240 | 1/260 |
| DepressionPsychiatric disorders | 1/240 | 0/260 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/240 | 0/260 |
| Social stay hospitalisationSocial circumstances | 1/240 | 0/260 |
| Event | Iloperidone Gradual Switch | Iloperidone Immediate Switch |
|---|---|---|
| DizzinessNervous system disorders | 42/240 | 58/260 |
| Dry mouthGastrointestinal disorders | 43/240 | 54/260 |
| SomnolenceNervous system disorders | 34/240 | 25/260 |
| Weight increasedInvestigations | 29/240 | 20/260 |
| InsomniaPsychiatric disorders | 20/240 | 25/260 |
| SedationNervous system disorders | 22/240 | 22/260 |
| FatigueGeneral disorders | 21/240 | 20/260 |
| HeadacheNervous system disorders | 17/240 | 19/260 |
| AnxietyPsychiatric disorders | 11/240 | 18/260 |
| NauseaGastrointestinal disorders | 13/240 | 17/260 |
| Age Continuous(years) | Iloperidone Gradual Switch | Iloperidone Immediate Switch | Total |
|---|---|---|---|
| Mean | 42.3 ± 10.98 | 44.2 ± 10.92 | 43.3 ± 10.98 |
| Sex: Female, Male(Participants) | Iloperidone Gradual Switch | Iloperidone Immediate Switch | Total |
|---|---|---|---|
| Female | 70 | 95 | 165 |
| Male | 170 | 165 | 335 |
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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