Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00868699
First received: March 23, 2009
Last updated: March 31, 2014
Last verified: March 2014
Results First Received: February 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Bipolar Depression
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
4/29/09 to 2/1/12

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo : Placebo Comparator
Lurasidone High Arm lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
Lurasidone Low Arm lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day

Participant Flow:   Overall Study
    Placebo     Lurasidone High Arm     Lurasidone Low Arm  
STARTED     170     169     166  
Intent-to-Treat Population     162     162     161  
Safety Population     168     167     164  
COMPLETED     127     124     123  
NOT COMPLETED     43     45     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.
Intent-to-treat population is analyzed.

Reporting Groups
  Description
Placebo Placebo : Placebo Comparator
Lurasidone High Arm lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
Lurasidone Low Arm lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
Total Total of all reporting groups

Baseline Measures
    Placebo     Lurasidone High Arm     Lurasidone Low Arm     Total  
Number of Participants  
[units: participants]
  162     162     161     485  
Age  
[units: participants]
       
<=18 years     0     0     3     3  
Between 18 and 65 years     159     159     155     473  
>=65 years     3     3     3     9  
Age  
[units: years]
Mean ± Standard Deviation
  41.2  ± 12.45     42.0  ± 12.35     41.3  ± 12.31     41.5  ± 12.35  
Gender  
[units: participants]
       
Female     87     98     91     276  
Male     75     64     70     209  
Region of Enrollment  
[units: participants]
       
France     5     4     4     13  
United States     58     70     67     195  
Czech Republic     19     19     17     55  
Ukraine     16     17     16     49  
Romania     9     2     4     15  
South Africa     18     17     19     54  
Russian Federation     10     10     11     31  
India     27     23     23     73  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)   [ Time Frame: Baseline to Week 6 ]

2.  Secondary:   Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)   [ Time Frame: Baseline to Week 6 ]

3.  Secondary:   Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score   [ Time Frame: Baseline to Week 6 ]


  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
No text entered.


  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: Medical Director, CNS
Organization: Sunovion
phone: 1-866-503-6351


Publications of Results:

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00868699     History of Changes
Other Study ID Numbers: D1050236, EUDRACT No. 2008-007457-13
Study First Received: March 23, 2009
Results First Received: February 14, 2013
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
India: Drugs Controller General of India
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Ukraine: Ministry of Health