Major Depressive Disorder With Mixed Features - Extension (RESOLVE3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01423253
First received: August 23, 2011
Last updated: September 15, 2015
Last verified: September 2015
Results First Received: September 15, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Intervention: Drug: Lurasidone

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Lurasidone 20, 40, 60 mg

Lurasidone 20, 40, or 60 mg/day flexibly dosed

Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed


Participant Flow:   Overall Study
    Lurasidone 20, 40, 60 mg  
STARTED     48  
COMPLETED     39  
NOT COMPLETED     9  
Adverse Event                 2  
Lack of Efficacy                 2  
Lost to Follow-up                 1  
Protocol Violation                 2  
Withdrawal by Subject                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Safety population

Reporting Groups
  Description
Lurasidone 20, 40, 60 mg

Lurasidone 20, 40, or 60 mg/day flexibly dosed

Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed


Baseline Measures
    Lurasidone 20, 40, 60 mg  
Number of Participants  
[units: participants]
  48  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     45  
>=65 years     2  
Age  
[units: Years]
Mean (Standard Deviation)
  42.5  (13.42)  
Gender  
[units: participants]
 
Female     36  
Male     12  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     21  
White     24  
More than one race     0  
Unknown or Not Reported     2  
Region of Enrollment  
[units: participants]
 
United States     48  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Subjects With Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: 12 Weeks ]

2.  Primary:   Proportion of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)   [ Time Frame: 12 Weeks ]

3.  Primary:   Proportion of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: 12 Weeks ]

4.  Secondary:   Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores   [ Time Frame: Baseline to12 Weeks ]

5.  Secondary:   Change From Baseline to Week 12 (LOCF) in CGI-S Score   [ Time Frame: baseline to week 12 ]

6.  Secondary:   Change From Baseline to Week 12 (LOCF) in the YMRS Total Score   [ Time Frame: Baseline to week 12 ]

7.  Secondary:   Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score   [ Time Frame: Baseline to week 12 ]

8.  Secondary:   Change From Baseline to Week 12 (LOCF) in the SDS Total Score   [ Time Frame: Baseline to week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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: 1-866-503-6351
Organization: Sunovion
phone: 1-866-503-6351
e-mail: clinicaltrialdisclosure@sunvion.com


No publications provided


Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01423253     History of Changes
Other Study ID Numbers: D1050306
Study First Received: August 23, 2011
Results First Received: September 15, 2015
Last Updated: September 15, 2015
Health Authority: United States: Food and Drug Administration