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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00088634
First received: July 30, 2004
Last updated: March 31, 2014
Last verified: March 2014

July 30, 2004
March 31, 2014
May 2004
December 2004   (final data collection date for primary outcome measure)
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately.
Not Provided
Complete list of historical versions of study NCT00088634 on ClinicalTrials.gov Archive Site
  • Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.
  • Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
  • Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Not Provided
Not Provided
Not Provided
 
A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia
A Double-blind Fixed-dose Study of SM-13496 and Placebo in the Treatment of Schizophrenia

A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Lurasidone
    80 mg AM dosing once daily
  • Drug: Placebo
    Matching Placebo to 40mg lurasidone tablets
  • Experimental: Lurasidone
    80 mg AM dosing once daily
    Intervention: Drug: Lurasidone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
December 2004
December 2004   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00088634
D1050196
No
Sunovion
Sunovion
Not Provided
Study Director: Medical Director, MD Sunovion
Sunovion
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP