A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00044044
First received: August 16, 2002
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 20 mg
Drug: Lurasidone 40mg
Drug: Lurasidone 80 mg
Drug: Haloperidol 10mg
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
20 mg Lurasidone 20 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 20mg group(overall study) is based on the total number of subjects randomized in this treatment group.
40 mg Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 40mg group(overall study) is based on the total number of subjects randomized in this treatment group.
80 mg Lurasidone 80 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 80mg group(overall study) is based on the total number of subjects randomized in this treatment group.
10 mg Haloperidol 10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow for the haloperidol 10mg group(overall study) is based on the total number of subjects randomized in this treatment group.
Placebo Oral Capsule matching treatment group taken oce a day. The number of subjects in the participant flow for the placebo group(overall study) is based on the total number of subjects randomized in this treatment group.

Participant Flow:   Overall Study
    20 mg     40 mg     80 mg     10 mg Haloperidol     Placebo  
STARTED     71     69     71     73     72  
COMPLETED     27     28     31     29     36  
NOT COMPLETED     44     41     40     44     36  



  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
20 mg Lurasidone 20 mg oral tablet taken once a day
40 mg Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. Two subjects who were randomized to the 40 mg treatment group did not take any study medication.
80 mg Lurasidone 80 mg oral tablet taken once a day
10 mg Haloperidol 10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 10 mg haloperidol treatment group did not take any study medication.
Placebo Oral Capsule matching treatment group taken oce a day
Total Total of all reporting groups

Baseline Measures
    20 mg     40 mg     80 mg     10 mg Haloperidol     Placebo     Total  
Number of Participants  
[units: participants]
  71     67     71     72     72     353  
Age  
[units: years]
Mean ± Standard Deviation
  40.7  ± 10.5     42.0  ± 10.9     42.2  ± 8.3     40.0  ± 10.5     41.0  ± 9.7     41.2  ± 10.0  
Gender  
[units: participants]
           
Female     20     21     19     14     17     91  
Male     51     46     52     58     55     262  



  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


No publications provided


Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00044044     History of Changes
Other Study ID Numbers: D1050049
Study First Received: August 16, 2002
Results First Received: February 1, 2011
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration