Clinical trial NCT00088621: A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia
Official title: An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Latuda
Lurasidone
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2004-08-02
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia

Detailed description: Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale \[AIMS\], Barnes Akathisia Scale \[BAS\], and Simpson-Angus Rating Scale \[SAS\]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.

Eligibility criteria: * Patients must have participated in study D1050196 (A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia) and either:
* Successfully completed
* OR
* Patients must have been discontinued after a minimum of 2 weeks of treatment due to lack of efficacy

Primary outcomes:
measure: Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharmaceutical
state: Alabama
city: Little Rock
country: United States
facility: Summit Research Group
state: Arkansas
city: Cerritos
country: United States
facility: Comprehensive NeuroScience
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuro Science Network, Inc.
state: California
city: La Mesa
country: United States
facility: Optimum Health Services
state: California
city: San Diego
country: United States
facility: California Clinical Trials
state: California
city: San Diego
country: United States
facility: CA Neutopsychopharmacology Clinical Research Institute (CNRI)
state: California
city: Upland
country: United States
facility: Pacific Clinical Research
state: California
city: Washington
country: United States
facility: Comprehensive NeuroScience, Inc
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Department of Psychiatry and Behavioral Medicine
state: Florida
city: Hoffman Estates
country: United States
facility: Comprehensive Neuroscience, Inc.
state: Illinois
city: Las Vegas
country: United States
state: Nevada
city: Clementon
country: United States
facility: CNS Research Institute
state: New Jersey
city: Philadelphia
country: United States
facility: Quantum Clinical Services Group
state: Pennsylvania
city: Austin
country: United States
facility: Community Clinical Research
state: Texas
city: Austin
country: United States
facility: Future Search Trials
state: Texas
city: Bellaire
country: United States
facility: Claghorn Lesem Research Clinic, Inc.
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Falls Church
country: United States
facility: CBH Health, L.L.C - Dominion Hospital
state: Virginia
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References: