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Major Depressive Disorder With Mixed Features - Extension (RESOLVE3)

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ClinicalTrials.gov Identifier: NCT01423253
Recruitment Status : Completed
First Posted : August 25, 2011
Results First Posted : October 14, 2015
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: Lurasidone
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lurasidone 20, 40, 60 mg
Hide Arm/Group Description

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

Period Title: Overall Study
Started 48
Completed 39
Not Completed 9
Reason Not Completed
Adverse Event             2
Lack of Efficacy             2
Lost to Follow-up             1
Protocol Violation             2
Withdrawal by Subject             2
Arm/Group Title Lurasidone 20, 40, 60 mg
Hide Arm/Group Description

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

Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
Safety population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
<=18 years
1
   2.1%
Between 18 and 65 years
45
  93.8%
>=65 years
2
   4.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
42.5  (13.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
36
  75.0%
Male
12
  25.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
21
  43.8%
White
24
  50.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
   4.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants
48
1.Primary Outcome
Title Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)
Hide Description Percentage of subjects with treatment emergent adverse events (TEAEs)
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Lurasidone 20, 40, 60 mg
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: percentage of subjects
66.7
2.Primary Outcome
Title Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)
Hide Description Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Lurasidone 20, 40, 60 mg
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: percentage of subjects
0
3.Primary Outcome
Title Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)
Hide Description Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Lurasidone 20, 40, 60 mg
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: percentage of subjects
4.2
4.Secondary Outcome
Title Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores
Hide Description Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject’s level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity.
Time Frame Baseline to12 Weeks
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Hide Analysis Population Description
Safety population - only 47 subjects had the MADRS assessment at Week 12 (LOCF).
Arm/Group Title Lurasidone 20, 40, 60 mg
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.9  (12.94)
5.Secondary Outcome
Title Change From Baseline to Week 12 (LOCF) in CGI-S Score
Hide Description The Clinical Global Impression - Severity of illness (CGI-S) score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.
Time Frame baseline to week 12
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Hide Analysis Population Description
Safety population - 1 subject did not have the CGI-S assessment at week 12 (LOCF)
Arm/Group Title Lurasidone 20, 40, 60 mg
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.47  (1.442)
6.Secondary Outcome
Title Change From Baseline to Week 12 (LOCF) in the YMRS Total Score
Hide Description The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population - 2 subject did not have YMRS assessment at week 12 (LOCF)
Arm/Group Title Lurasidone 20, 40, 60 mg
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.5  (6.17)
7.Secondary Outcome
Title Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score
Hide Description The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population - 4 subjects did not have the HAM-A assessment at week 12 (LOCF)
Arm/Group Title Lurasidone 20, 40, 60 mg
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.5  (6.48)
8.Secondary Outcome
Title Change From Baseline to Week 12 (LOCF) in the SDS Total Score
Hide Description The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient’s life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1–3 (mild), 4–6 (moderate), 7–9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population - 12 subjects did not have the SDS total score at week 12 (LOCF)
Arm/Group Title Lurasidone 20, 40, 60 mg
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.6  (9.95)
Time Frame 12 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lurasidone 20, 40, 60 mg
Hide Arm/Group Description

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

All-Cause Mortality
Lurasidone 20, 40, 60 mg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lurasidone 20, 40, 60 mg
Affected / at Risk (%) # Events
Total   0/48 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lurasidone 20, 40, 60 mg
Affected / at Risk (%) # Events
Total   16/48 (33.33%)    
Gastrointestinal disorders   
Diarrhoea  1  4/48 (8.33%)  4
Nausea  1  3/48 (6.25%)  3
General disorders   
Fatigue  1  3/48 (6.25%)  3
Infections and infestations   
Upper respiratory tract infection  1  4/48 (8.33%)  4
Nervous system disorders   
Akathisia  1  5/48 (10.42%)  6
Headache  1  3/48 (6.25%)  4
Sedation  1  3/48 (6.25%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.

There IS agreement between Principal Investigator and Sponsor that restricts PI's rights to discuss or publish trial results after trial is completed.

In addition to the <60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication provided, if a multicenter publication is not forthcoming within 24 months post completion of study at all sites, PI shall be free to publish.

Results Point of Contact
Name/Title: 1-866-503-6351
Organization: Sunovion
Phone: 1-866-503-6351
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01423253     History of Changes
Other Study ID Numbers: D1050306
First Submitted: August 23, 2011
First Posted: August 25, 2011
Results First Submitted: September 15, 2015
Results First Posted: October 14, 2015
Last Update Posted: April 8, 2016