Clinical trial NCT00044005: Safety and Tolerability Study of Drug to Treat Schizophrenia
Official title: A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With 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: 2002-08-20
Enrollment: 98
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 evaluate the long-term safety of SM-13496 in patients with schizophrenia.


Eligibility criteria: Inclusion criteria:

* Successful completion of participation in protocol #D1050049

Exclusion criteria:

* Substance abuse
* Prolactin level of ≥200ng/mL at baseline
* Pregnancy

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharmaceutical
state: Alabama
city: Cerritos
country: United States
facility: Institute for Psychopharmacology Research
state: California
city: Garden Grove
country: United States
facility: CNS Network
state: California
city: Glendale
country: United States
facility: California Clinical Trials Medical Group
state: California
city: La Mesa
country: United States
facility: Optimum Health Services
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: San Diego
country: United States
facility: California Neuropsychopharmacology Clinical Research Institute
state: California
city: Washington
country: United States
facility: Psychiatric Institute of Washington
state: District of Columbia
city: Melbourne
country: United States
facility: Comprehensive Neuroscience. Inc.
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
state: Florida
city: Winter Park
country: United States
facility: Coordinated Research of Florida, Inc
state: Florida
city: Honolulu
country: United States
facility: Hawaii Research Center
state: Hawaii
city: Hoffman Estates
country: United States
facility: Alexian Brothers Behavioral Health Hospital
state: Illinois
city: Oakbrook
country: United States
facility: American Medical Research
state: Illinois
city: North Las Vegas
country: United States
facility: Lake Mead Hospital
state: Nevada
city: Clementon
country: United States
facility: Comprehensive Clinical Research, CNS
state: New Jersey
city: Kenilworth
country: United States
facility: ClinSearch, Inc.
state: New Jersey
city: Philadelphia
country: United States
facility: Quantum Clinical Services Group
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Community Clinical Research
state: Texas
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Bellaire
country: United States
facility: Claghorn Lesem Research Clinic, Inc.
state: Texas
city: Dallas
country: United States
facility: St. Paul Medical Center
state: Texas
city: Falls Church
country: United States
facility: CNS, Inc.
state: Virginia
city: Milwaukee
country: United States
facility: Medstream, Inc.
state: Wisconsin
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References: