A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia - Tabular View

Tracking Information
First Received Date ^ICMJE	July 30, 2004
Last Updated Date	July 9, 2008
Start Date ^ICMJE	May 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00088634 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia
Official Title ^ICMJE	A Double-Blind Fixed-Dose Study Antipsychotic and Placebo in the Treatment of Schizophrenia
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).
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Schizophrenia
Intervention ^ICMJE	Drug: SM-13496
Study Arms / Comparison Groups
Publications *	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. Epub 2009 Jun 2.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	160
Completion Date	December 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00088634
Responsible Party
Study ID Numbers ^ICMJE	D1050196
Study Sponsor ^ICMJE	Sumitomo Pharmaceuticals America
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Sumitomo Pharmaceuticals America
Verification Date	December 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP