Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00615433
First received: February 1, 2008
Last updated: April 9, 2013
Last verified: April 2013
Results First Received: November 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Lurasidone
Drug: Olanzapine
Drug: Placebo comparator
Drug: Lurasidone 40 mg tablets

  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
No text entered.

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
40mg Lurasidone 40 mg 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 (478). The number of subjects in the baseline characteristics is based on the safety population (475). 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 40 mg treatment group did not take any study medication.
120mg 3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). 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 120 mg treatment group did not take any study medication.
15mg Olz 3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). 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 15 mg Olanzapine treatment group did not take any study medication.
Placebo Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).

Participant Flow:   Overall Study
    40mg     120mg     15mg Olz     Placebo  
STARTED     120     119     123     116  
COMPLETED     77     66     84     71  
NOT COMPLETED     43     53     39     45  



  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.
No text entered.

Reporting Groups
  Description
40mg Lurasidone 40 mg 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 (478). The number of subjects in the baseline characteristics is based on the safety population (475). 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 40 mg treatment group did not take any study medication.
120mg 3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). 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 120 mg treatment group did not take any study medication.
15mg Olz 3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). 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 15 mg Olanzapine treatment group did not take any study medication.
Placebo Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
Total Total of all reporting groups

Baseline Measures
    40mg     120mg     15mg Olz     Placebo     Total  
Number of Participants  
[units: participants]
  119     118     122     116     475  
Age  
[units: years]
Mean ± Standard Deviation
  37.7  ± 11.0     37.9  ± 11.2     38.3  ± 10.2     36.9  ± 11.3     37.7  ± 10.9  
Gender  
[units: participants]
         
Female     26     25     27     26     104  
Male     93     93     95     90     371  
Region of Enrollment  
[units: participants]
         
United States     70     72     74     68     284  
Philippines     7     6     8     5     26  
Lithuania     7     7     7     8     29  
Colombia     12     12     12     12     48  
India     23     21     21     23     88  



  Outcome Measures
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1.  Primary:   Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.   [ Time Frame: Baseline and 6 weeks ]

2.  Secondary:   CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.   [ Time Frame: 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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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


Publications of Results:

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00615433     History of Changes
Other Study ID Numbers: D1050231
Study First Received: February 1, 2008
Results First Received: November 8, 2010
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration