Clinical trial NCT00044044: A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia
Official title: A 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms
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: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.


Eligibility criteria: Inclusion criteria:

* The patient has a primary diagnosis of schizophrenia
* The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening
* The patient has had a duration of illness of at least one year.
* The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS
* The patient is able to remain off antipsychotic medication for a 4 day washout period

Exclusion criteria:

* The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening.
* The patient is considered treatment resistant-Substance abuse-Prolactin level of \> 200 ng/mL at baseline
* Pregnancy

Primary outcomes:
measure: Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
timeFrame: Baseline and 6 weeks
measure: Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
timeFrame: Baseline and 6 weeks
measure: Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
timeFrame: Baseline and 6 weeks
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: Affiliated Research Institute
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: San Diego
country: United States
facility: California Neuropsychopharmacolgoy Clinical Research Insitute
state: California
city: Washington
country: United States
facility: Comprehensive Neuroscience. Inc.
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: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
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: Rockville
country: United States
facility: Centers for Behavioral Health, LLC
state: Maryland
city: North Las Vegas
country: United States
facility: Lake Mead Hospital
state: Nevada
city: Clementon
country: United States
facility: Comprehensive Clinical Research CNS, PC
state: New Jersey
city: Kenilworth
country: United States
facility: ClinSearch, Inc.
state: New Jersey
city: Cincinnati
country: United States
facility: Psychiatric Professional Services Inc
state: Ohio
city: Philadelphia
country: United States
facility: Quantum Clinical Services Group
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center - Dept. of Psychiatry
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: Dallas
country: United States
facility: University Hills Clinical Research
state: Texas
city: Falls Church
country: United States
facility: CNS, Inc.
state: Virginia
city: Belleview
country: United States
facility: Northwest Clinical Research Center
state: Washington
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: