Clinical trial NCT00254202: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Atypical antipsychotic
Psychosis
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 593
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia
* PANSS-T of at least 70 at screening and baseline

Exclusion Criteria:

* Clinically significant disease of the heart, kidneys, liver or gastrointestinal system
* DSM-IV diagnosis of psychiatric disorder other than schizophrenia

Primary outcomes:
measure: Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Vanda Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Vanda Investigational Site
state: California
city: Cerritos
country: United States
facility: Vanda Investigational Site
state: California
city: Garden Grove
country: United States
facility: Vanda Investigational Site
state: California
city: Glendale
country: United States
facility: Vanda Investigational Site
state: California
city: Los Angeles
country: United States
facility: Vanda Investigational Site
state: California
city: National City
country: United States
facility: Vanda Investigational Site
state: California
city: Oceanside
country: United States
facility: Vanda Investigational Site
state: California
city: Paramount
country: United States
facility: Vanda Investigational Site
state: California
city: Pico Rivera
country: United States
facility: Vanda Investigational Site
state: California
city: San Diego
country: United States
facility: Vanda Investigational Site
state: California
city: San Diego
country: United States
facility: Vanda Investigational Site
state: California
city: San Diego
country: United States
facility: Vanda Investigational Site
state: California
city: Santa Ana
country: United States
facility: Vanda Investigational Site
state: California
city: Upland
country: United States
facility: Vanda Investigational Site
state: California
city: Bradenton
country: United States
facility: Vanda Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Vanda Investigational Site
state: Florida
city: Maitland
country: United States
facility: Vanda Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Hoffman Estates
country: United States
facility: Vanda Investigational Site
state: Illinois
city: Lake Charles
country: United States
facility: Vanda Investigational Site
state: Louisiana
city: Rockville
country: United States
facility: Vanda Investigational Site
state: Maryland
city: Saint Charles
country: United States
facility: Vanda Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Vanda Investigational Site
state: Missouri
city: Clementon
country: United States
facility: Vanda Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Vanda Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Vanda Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Vanda Investigational Site
state: Texas
city: Houston
country: United States
facility: Vanda Investigational Site
state: Texas
city: Irving
country: United States
facility: Vanda Investigational Site
state: Texas
city: Richmond
country: United States
facility: Vanda Investigational Site
state: Virginia
city: Tirupati
country: India
facility: Vanda Investigational Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Vanda Investigational Site
state: Gujarat
city: Manipal
country: India
facility: Vanda Investigational Site
state: Karnataka
city: Aurangabad
country: India
facility: Vanda Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Vanda Investigational Site
state: Maharashtra
city: Jaipur
country: India
facility: Vanda Investigational Site
state: Rajasthan
city: Chennai
country: India
facility: Vanda Investgational Site
state: Tamilnadu
city: Lucknow
country: India
facility: Vanda Investigational Site
state: UP
city: Chinawaltair
country: India
facility: Vanda Investigational Site
state: Visakha Patnam
Study officials:
References:
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.