Clinical trial NCT00088634: A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia
Official title: A Double-blind Fixed-dose Study of Lurasidone (SM-13496) and Placebo 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: 180
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: A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia

Detailed description: Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).

Eligibility criteria: Inclusion Criteria:

* Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV
* The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment
* If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception

Exclusion Criteria:

* The patient has used an investigational drug within the past 30 days
* The patient has participated in a previous study of this compound

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: 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: CNRI, LLC San Diego
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: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: North Miami
country: United States
facility: The Segal Institute
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Department of Psychiatry and Behavioral Medicine
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Hoffman Estates
country: United States
facility: Comprehensive Neuroscience, Inc.
state: Illinois
city: Las Vegas
country: United States
facility: Robert Lynn Horne, MD, Suite 4
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
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:
citation: Nakamura M, Ogasa M, Guarino J, Phillips D, Severs J, Cucchiaro J, Loebel A. Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 Jun;70(6):829-36. doi: 10.4088/JCP.08m04905. Epub 2009 Jun 2.
citation: Hopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.
citation: Nasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.