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

Sponsor

Vanda Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00254202

Collaborator

(none)

600

Enrollment

Locations

15.9

Duration (Months)

14.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: iloperidone Drug: active comparator Drug: placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Sep 1, 2006

Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

Positive and Negative Symptom Scale (PANSS) - Total Score []

Secondary Outcome Measures

Pharmacogenetic analysis []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanda Investigational Site	Little Rock	Arkansas	United States	72211
2	Vanda Investigational Site	Anaheim	California	United States	92805
3	Vanda Investigational Site	Cerritos	California	United States	90703
4	Vanda Investigational Site	Garden Grove	California	United States	92845
5	Vanda Investigational Site	Glendale	California	United States	91206
6	Vanda Investigational Site	Los Angeles	California	United States	90048
7	Vanda Investigational Site	National City	California	United States	91950
8	Vanda Investigational Site	Oceanside	California	United States	92056
9	Vanda Investigational Site	Paramount	California	United States	90723
10	Vanda Investigational Site	Pico Rivera	California	United States	90660
11	Vanda Investigational Site	San Diego	California	United States	92123
12	Vanda Investigational Site	San Diego	California	United States	92126
13	Vanda Investigational Site	San Diego	California	United States	92161
14	Vanda Investigational Site	Santa Ana	California	United States	92705
15	Vanda Investigational Site	Upland	California	United States	91786
16	Vanda Investigational Site	Bradenton	Florida	United States	34208
17	Vanda Investigational Site	Ft. Lauderdale	Florida	United States	33308
18	Vanda Investigational Site	Maitland	Florida	United States	32751
19	Vanda Investigational Site	Atlanta	Georgia	United States	30308
20	Vanda Investigational Site	Augusta	Georgia	United States	30912
21	Vanda Investigational Site	Hoffman Estates	Illinois	United States	60194
22	Vanda Investigational Site	Lake Charles	Louisiana	United States	70601
23	Vanda Investigational Site	Rockville	Maryland	United States	20850
24	Vanda Investigational Site	St. Charles	Missouri	United States	63301
25	Vanda Investigational Site	St. Louis	Missouri	United States	63118
26	Vanda Investigational Site	Clementon	New Jersey	United States	08021
27	Vanda Investigational Site	Brooklyn	New York	United States	11203
28	Vanda Investigational Site	Cincinnati	Ohio	United States	45267
29	Vanda Investigational Site	Philadelphia	Pennsylvania	United States	19131
30	Vanda Investigational Site	Austin	Texas	United States	78756
31	Vanda Investigational Site	Houston	Texas	United States	77057
32	Vanda Investigational Site	Irving	Texas	United States	75062
33	Vanda Investigational Site	Richmond	Virginia	United States	23229
34	Vanda Investigational Site	Tirupati	Andhra Pradesh	India	517507
35	Vanda Investigational Site	Ahmedabad	Gujarat	India	380006
36	Vanda Investigational Site	Manipal	Karnataka	India	576104
37	Vanda Investigational Site	Aurangabad	Maharashtra	India	431005
38	Vanda Investigational Site	Pune	Maharashtra	India	411001
39	Vanda Investigational Site	Jaipur	Rajasthan	India	302004
40	Vanda Investgational Site	Chennai	Tamilnadu	India	600003
41	Vanda Investigational Site	Lucknow	UP	India	226003
42	Vanda Investigational Site	Chinawaltair	Visakha Patnam	India	530002