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Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
iloperidone
active comparator
placebo
Sponsored by
Vanda Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Atypical antipsychotic, psychosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject with schizophrenia. Subject must sign a written consent form. Exclusion Criteria: Clinically significant disease of the heart, kidneys, liver or gastrointestinal system Psychiatric disorder other than schizophrenia

Sites / Locations

  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investgational Site
  • Vanda Investigational Site
  • Vanda Investigational Site

Outcomes

Primary Outcome Measures

Positive and Negative Symptom Scale (PANSS) - Total Score

Secondary Outcome Measures

Pharmacogenetic analysis

Full Information

First Posted
November 10, 2005
Last Updated
July 18, 2012
Sponsor
Vanda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00254202
Brief Title
Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Vanda Pharmaceuticals

4. Oversight

5. Study Description

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.
Detailed Description
Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to recall and learn new information. Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Atypical antipsychotic, psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
iloperidone
Intervention Type
Drug
Intervention Name(s)
active comparator
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Positive and Negative Symptom Scale (PANSS) - Total Score
Secondary Outcome Measure Information:
Title
Pharmacogenetic analysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject with schizophrenia. Subject must sign a written consent form. Exclusion Criteria: Clinically significant disease of the heart, kidneys, liver or gastrointestinal system Psychiatric disorder other than schizophrenia
Facility Information:
Facility Name
Vanda Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Vanda Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Vanda Investigational Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Vanda Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Vanda Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Vanda Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Vanda Investigational Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Vanda Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Vanda Investigational Site
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Vanda Investigational Site
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Vanda Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Vanda Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
Facility Name
Vanda Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Vanda Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Vanda Investigational Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Vanda Investigational Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Vanda Investigational Site
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Vanda Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Vanda Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Vanda Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Vanda Investigational Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Vanda Investigational Site
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Vanda Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Vanda Investigational Site
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Vanda Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Vanda Investigational Site
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Vanda Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Vanda Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Vanda Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
Vanda Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Vanda Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
Vanda Investigational Site
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Vanda Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Vanda Investigational Site
City
Tirupati
State/Province
Andhra Pradesh
ZIP/Postal Code
517507
Country
India
Facility Name
Vanda Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Vanda Investigational Site
City
Manipal
State/Province
Karnataka
ZIP/Postal Code
576104
Country
India
Facility Name
Vanda Investigational Site
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431005
Country
India
Facility Name
Vanda Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Vanda Investigational Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Facility Name
Vanda Investgational Site
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600003
Country
India
Facility Name
Vanda Investigational Site
City
Lucknow
State/Province
UP
ZIP/Postal Code
226003
Country
India
Facility Name
Vanda Investigational Site
City
Chinawaltair
State/Province
Visakha Patnam
ZIP/Postal Code
530002
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
19573479
Citation
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 Reference
derived

Learn more about this trial

Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia

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