Trial Outcomes & Findings for Major Depressive Disorder With Mixed Features

Results Overview

Percentage of subjects with treatment emergent adverse events (TEAEs)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

48 participants

Primary outcome timeframe

12 Weeks

Results posted on

2016-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	48
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	2
Overall Study Lack of Efficacy	2
Overall Study Lost to Follow-up	1
Overall Study Protocol Violation	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Major Depressive Disorder With Mixed Features - Extension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lurasidone 20, 40, 60 mg n=48 Participants 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
Age, Categorical <=18 years	1 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Age, Continuous	42.5 Years STANDARD_DEVIATION 13.42 • n=99 Participants
Sex: Female, Male Female	36 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	21 Participants n=99 Participants
Race (NIH/OMB) White	24 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Region of Enrollment United States	48 participants n=99 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Population: Safety population

Percentage of subjects with treatment emergent adverse events (TEAEs)

Outcome measures

Outcome measures
Measure	Lurasidone 20, 40, 60 mg n=48 Participants 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
Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)	66.7 percentage of subjects

PRIMARY outcome

Timeframe: 12 Weeks

Population: Safety Population

Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)

Outcome measures

Outcome measures
Measure	Lurasidone 20, 40, 60 mg n=48 Participants 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
Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)	0 percentage of subjects

PRIMARY outcome

Timeframe: 12 Weeks

Population: Safety Population

Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)

Outcome measures

Outcome measures
Measure	Lurasidone 20, 40, 60 mg n=48 Participants 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
Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)	4.2 percentage of subjects

SECONDARY outcome

Timeframe: Baseline to12 Weeks

Population: Safety population - only 47 subjects had the MADRS assessment at Week 12 (LOCF).

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.

Outcome measures

Outcome measures
Measure	Lurasidone 20, 40, 60 mg n=47 Participants 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
Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores	-5.9 units on a scale Standard Deviation 12.94

SECONDARY outcome

Timeframe: baseline to week 12

Population: Safety population - 1 subject did not have the CGI-S assessment at week 12 (LOCF)

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.

Outcome measures

Outcome measures
Measure	Lurasidone 20, 40, 60 mg n=47 Participants 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
Change From Baseline to Week 12 (LOCF) in CGI-S Score	-0.47 units on a scale Standard Deviation 1.442

SECONDARY outcome

Timeframe: Baseline to week 12

Population: Safety population - 2 subject did not have YMRS assessment at week 12 (LOCF)

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.

Outcome measures

Outcome measures
Measure	Lurasidone 20, 40, 60 mg n=46 Participants 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
Change From Baseline to Week 12 (LOCF) in the YMRS Total Score	-1.5 units on a scale Standard Deviation 6.17

SECONDARY outcome

Timeframe: Baseline to week 12

Population: Safety Population - 4 subjects did not have the HAM-A assessment at week 12 (LOCF)

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.

Outcome measures

Outcome measures
Measure	Lurasidone 20, 40, 60 mg n=44 Participants 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
Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score	-1.5 units on a scale Standard Deviation 6.48

SECONDARY outcome

Timeframe: Baseline to week 12

Population: Safety Population - 12 subjects did not have the SDS total score at week 12 (LOCF)

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).

Outcome measures

Outcome measures
Measure	Lurasidone 20, 40, 60 mg n=36 Participants 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
Change From Baseline to Week 12 (LOCF) in the SDS Total Score	-3.6 units on a scale Standard Deviation 9.95

Adverse Events

Lurasidone 20, 40, 60 mg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lurasidone 20, 40, 60 mg n=48 participants at risk 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
Gastrointestinal disorders Diarrhoea	8.3% 4/48 • Number of events 4 • 12 Weeks
Gastrointestinal disorders Nausea	6.2% 3/48 • Number of events 3 • 12 Weeks
General disorders Fatigue	6.2% 3/48 • Number of events 3 • 12 Weeks
Infections and infestations Upper respiratory tract infection	8.3% 4/48 • Number of events 4 • 12 Weeks
Nervous system disorders Akathisia	10.4% 5/48 • Number of events 6 • 12 Weeks
Nervous system disorders Headache	6.2% 3/48 • Number of events 4 • 12 Weeks
Nervous system disorders Sedation	6.2% 3/48 • Number of events 3 • 12 Weeks

Additional Information

1-866-503-6351

Sunovion

Phone: 1-866-503-6351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER