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
Results First Received: February 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Lurasidone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lurasidone 80 mg 2 40 mg lurasidone tablets taken once/day
Placebo Matching placebo to lurasidone 40 mg tablets taken once/day

Participant Flow:   Overall Study
    Lurasidone 80 mg     Placebo  
STARTED     90     90  
COMPLETED     52     47  
NOT COMPLETED     38     43  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Lurasidone 80 mg 2 40 mg lurasidone tablets taken once/day
Placebo Matching placebo to lurasidone 40 mg tablets taken once/day
Total Total of all reporting groups

Baseline Measures
    Lurasidone 80 mg     Placebo     Total  
Number of Participants  
[units: participants]
  90     90     180  
Age  
[units: years]
Mean ± Standard Deviation
  39.7  ± 9.91     41.9  ± 9.78     40.8  ± 9.88  
Gender  
[units: participants]
     
Female     22     20     42  
Male     68     70     138  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Josephine Cucchiaro, Executive Director
Organization: Sunovion
phone: 201-592-2050
e-mail: josephine.cucchiaro@sunovion.com


Publications of Results:

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00088634     History of Changes
Other Study ID Numbers: D1050196
Study First Received: July 30, 2004
Results First Received: February 1, 2011
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration