Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia
A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Iloperidone in Schizophrenic Patients in Acute Exacerbation Followed by a Long-term Treatment Phase.
1 other identifier
interventional
593
2 countries
42
Brief Summary
The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Nov 2005
Shorter than P25 for phase_3 schizophrenia
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedStudy Start
First participant enrolled
November 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2007
CompletedResults Posted
Study results publicly available
December 13, 2024
CompletedDecember 13, 2024
December 1, 2024
10 months
November 10, 2005
April 1, 2024
December 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Iloperidone
EXPERIMENTALOral iloperidone
Ziprasidone
ACTIVE COMPARATOROral ziprasidone
Placebo
PLACEBO COMPARATOROral placebo
Interventions
Eligibility Criteria
You may qualify if:
- DSM-IV diagnosis of schizophrenia
- PANSS-T of at least 70 at screening and baseline
You may not qualify if:
- Clinically significant disease of the heart, kidneys, liver or gastrointestinal system
- DSM-IV diagnosis of psychiatric disorder other than schizophrenia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Vanda Investigational Site
Little Rock, Arkansas, 72211, United States
Vanda Investigational Site
Anaheim, California, 92805, United States
Vanda Investigational Site
Cerritos, California, 90703, United States
Vanda Investigational Site
Garden Grove, California, 92845, United States
Vanda Investigational Site
Glendale, California, 91206, United States
Vanda Investigational Site
Los Angeles, California, 90048, United States
Vanda Investigational Site
National City, California, 91950, United States
Vanda Investigational Site
Oceanside, California, 92056, United States
Vanda Investigational Site
Paramount, California, 90723, United States
Vanda Investigational Site
Pico Rivera, California, 90660, United States
Vanda Investigational Site
San Diego, California, 92123, United States
Vanda Investigational Site
San Diego, California, 92126, United States
Vanda Investigational Site
San Diego, California, 92161, United States
Vanda Investigational Site
Santa Ana, California, 92705, United States
Vanda Investigational Site
Upland, California, 91786, United States
Vanda Investigational Site
Bradenton, Florida, 34208, United States
Vanda Investigational Site
Fort Lauderdale, Florida, 33308, United States
Vanda Investigational Site
Maitland, Florida, 32751, United States
Vanda Investigational Site
Atlanta, Georgia, 30308, United States
Vanda Investigational Site
Augusta, Georgia, 30912, United States
Vanda Investigational Site
Hoffman Estates, Illinois, 60194, United States
Vanda Investigational Site
Lake Charles, Louisiana, 70601, United States
Vanda Investigational Site
Rockville, Maryland, 20850, United States
Vanda Investigational Site
Saint Charles, Missouri, 63301, United States
Vanda Investigational Site
St Louis, Missouri, 63118, United States
Vanda Investigational Site
Clementon, New Jersey, 08021, United States
Vanda Investigational Site
Brooklyn, New York, 11203, United States
Vanda Investigational Site
Cincinnati, Ohio, 45267, United States
Vanda Investigational Site
Philadelphia, Pennsylvania, 19131, United States
Vanda Investigational Site
Austin, Texas, 78756, United States
Vanda Investigational Site
Houston, Texas, 77057, United States
Vanda Investigational Site
Irving, Texas, 75062, United States
Vanda Investigational Site
Richmond, Virginia, 23229, United States
Vanda Investigational Site
Tirupati, Andhra Pradesh, 517507, India
Vanda Investigational Site
Ahmedabad, Gujarat, 380006, India
Vanda Investigational Site
Manipal, Karnataka, 576104, India
Vanda Investigational Site
Aurangabad, Maharashtra, 431005, India
Vanda Investigational Site
Pune, Maharashtra, 411001, India
Vanda Investigational Site
Jaipur, Rajasthan, 302004, India
Vanda Investgational Site
Chennai, Tamil Nadu, 600003, India
Vanda Investigational Site
Lucknow, Uttar Pradesh, 226003, India
Vanda Investigational Site
Chinawaltair, Visakha Patnam, 530002, India
Related Publications (1)
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.
PMID: 19573479DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vanda Pharmaceuticals
- Organization
- Vanda Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2005
First Posted
November 15, 2005
Study Start
November 18, 2005
Primary Completion
September 26, 2006
Study Completion
March 21, 2007
Last Updated
December 13, 2024
Results First Posted
December 13, 2024
Record last verified: 2024-12