Efficacy and Safety of Iloperidone Compared With Placebo... | NCT00254202

Status Module

Description Module

Label	Type	Description	Intervention Names
Iloperidone	Experimental	Oral iloperidone	Drug: Iloperidone
Ziprasidone	Active Comparator	Oral ziprasidone	Drug: Ziprasidone
Placebo	Placebo Comparator	Oral placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Iloperidone	Drug		Iloperidone	Fanapt® VYV-683
Ziprasidone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score	The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.	4 weeks

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Vanda Investigational Site		Little Rock	Arkansas	72211	United States
Vanda Investigational Site

PubMed Identifier	Type	Citation	Retractions
19573479	Derived	Volpi S, Potkin SG, Malhotra AK, Licamele L, Lavedan C. Applicability of a genetic signature for enhanced iloperidone efficacy in the treatment of schizophrenia. J Clin Psychiatry. 2009 Jun;70(6):801-9. doi: 10.4088/jcp.08m04391.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Iloperidone	Oral iloperidone
FG001	Ziprasidone	Oral ziprasidone
FG002

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score

The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.

The modified Intent-to-Treat (ITT) population comprise all randomized patients who receive at least one dose of study medication in the short-term double-blind phase and for whom a baseline PANSS score measurement is obtained and at least one post-baseline PANSS score measurement is obtained while on study medication. For patients randomized in error at a second site after being randomized once, the data from the second site were excluded from analysis in the modified ITT population.

Posted

Mean

Standard Error

score on a scale

4 weeks

ID	Title	Description
OG000	Iloperidone	Oral iloperidone
OG001	Ziprasidone	Oral ziprasidone
OG002	Placebo	Oral placebo

Units	Counts
Participants	OG000283 OG001144 OG002140

Title

Denominators

Categories

Title	Measurements
	OG000-12.0± 1.03 OG001-12.3± 1.44 OG002-7.1± 1.48

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Microcytic anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected300 at risk EG0010 affected150 at risk EG0020 affected147 at risk
Psychotic disorder	Psychiatric disorders	Systematic Assessment	EG0001 affected300 at risk EG0012 affected150 at risk EG0020 affected147 at risk
Bradycardia	Cardiac disorders	Systematic Assessment	EG0000 affected300 at risk EG0010 affected150 at risk EG0021 affected147 at risk
Chest pain	General disorders	Systematic Assessment	EG0000 affected300 at risk EG0010 affected150 at risk EG0021 affected147 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0000 affected300 at risk EG0010 affected150 at risk EG0021 affected147 at risk
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected300 at risk EG0010 affected150 at risk EG0021 affected147 at risk
Convulsion	Nervous system disorders	Systematic Assessment	EG0000 affected300 at risk EG0010 affected150 at risk EG0022 affected147 at risk
Schizophrenia	Psychiatric disorders	Systematic Assessment	EG0000 affected300 at risk EG0010 affected150 at risk EG0021 affected147 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Dizziness	Nervous system disorders	Systematic Assessment	EG00051 affected300 at risk EG00120 affected150 at risk EG00211 affected147 at risk
Sedation	Nervous system disorders	Systematic Assessment	EG00038 affected300 at risk EG00141 affected150 at risk EG00212 affected147 at risk
Weight increased	Investigations	Systematic Assessment	EG00034 affected300 at risk EG0017 affected150 at risk EG0023 affected147 at risk
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG00026 affected300 at risk EG00111 affected150 at risk EG0021 affected147 at risk
Heart rate increased	Investigations	Systematic Assessment	EG00024 affected300 at risk EG0019 affected150 at risk EG0021 affected147 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00025 affected300 at risk EG0015 affected150 at risk EG0024 affected147 at risk
Tachycardia	Cardiac disorders	Systematic Assessment	EG00028 affected300 at risk EG0013 affected150 at risk EG0021 affected147 at risk
Extrapyramidal disorder	Nervous system disorders	Systematic Assessment	EG00010 affected300 at risk EG00114 affected150 at risk EG0023 affected147 at risk
Agitation	Psychiatric disorders	Systematic Assessment	EG00010 affected300 at risk EG00110 affected150 at risk EG0024 affected147 at risk
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG00021 affected300 at risk EG0010 affected150 at risk EG0023 affected147 at risk
Somnolence	Nervous system disorders	Systematic Assessment	EG00012 affected300 at risk EG0019 affected150 at risk EG0022 affected147 at risk
Restlessness	Psychiatric disorders	Systematic Assessment	EG00011 affected300 at risk EG0018 affected150 at risk EG0023 affected147 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG0009 affected300 at risk EG0018 affected150 at risk EG0021 affected147 at risk
Akathisia	Nervous system disorders	Systematic Assessment	EG0004 affected300 at risk EG00111 affected150 at risk EG0020 affected147 at risk
Headache	Nervous system disorders	Systematic Assessment	EG00061 affected300 at risk EG00135 affected150 at risk EG00229 affected147 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00029 affected300 at risk EG00121 affected150 at risk EG00213 affected147 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG00024 affected300 at risk EG00115 affected150 at risk EG00215 affected147 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG00027 affected300 at risk EG00112 affected150 at risk EG00214 affected147 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG00017 affected300 at risk EG00116 affected150 at risk EG00210 affected147 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG00020 affected300 at risk EG00112 affected150 at risk EG00210 affected147 at risk
Fatigue	General disorders	Systematic Assessment	EG00016 affected300 at risk EG0019 affected150 at risk EG0027 affected147 at risk
Stomach discomfort	Gastrointestinal disorders	Systematic Assessment	EG00013 affected300 at risk EG0017 affected150 at risk EG0028 affected147 at risk
Toothache	Gastrointestinal disorders	Systematic Assessment	EG00014 affected300 at risk EG0016 affected150 at risk EG0028 affected147 at risk
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0004 affected300 at risk EG0016 affected150 at risk EG0028 affected147 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG00014 affected300 at risk EG00110 affected150 at risk EG0029 affected147 at risk

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Title	Description
BG000	Iloperidone	Oral iloperidone
BG001	Ziprasidone	Oral ziprasidone
BG002	Placebo	Oral placebo
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Iloperidone	Oral iloperidone	300	2	300	221	300
EG001	Ziprasidone	Oral ziprasidone	150	2	150	118	150
EG002	Placebo	Oral placebo	147	5	147	86	147