Trial Outcomes & Findings for Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression (NCT NCT00868959)

NCT ID: NCT00868959

Last Updated: 2016-04-14

Results Overview

Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 817 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2016-04-14

Participant Flow

817 represents the total number of subjects who provided informed consent and enrolled, which is different from the total number of subjects who were treated with study drug, which was 813.

Participant milestones

Measure	Lurasidone lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Overall Study STARTED	817
Overall Study COMPLETED	559
Overall Study NOT COMPLETED	258

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

Baseline characteristics by cohort

Measure	Lurasidone n=813 Participants lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Age, Continuous	42.7 years STANDARD_DEVIATION 12.03 • n=5 Participants
Age, Categorical <=18 years	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	790 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Sex: Female, Male Female	427 Participants n=5 Participants
Sex: Female, Male Male	386 Participants n=5 Participants
Region of Enrollment United States	283 participants n=5 Participants
Region of Enrollment Slovakia	19 participants n=5 Participants
Region of Enrollment Ukraine	78 participants n=5 Participants
Region of Enrollment Lithuania	16 participants n=5 Participants
Region of Enrollment Russian Federation	31 participants n=5 Participants
Region of Enrollment Colombia	15 participants n=5 Participants
Region of Enrollment India	128 participants n=5 Participants
Region of Enrollment France	23 participants n=5 Participants
Region of Enrollment Czech Republic	108 participants n=5 Participants
Region of Enrollment Canada	14 participants n=5 Participants
Region of Enrollment Poland	12 participants n=5 Participants
Region of Enrollment Romania	9 participants n=5 Participants
Region of Enrollment Peru	12 participants n=5 Participants
Region of Enrollment South Africa	56 participants n=5 Participants
Region of Enrollment Japan	6 participants n=5 Participants
Region of Enrollment Germany	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)

Outcome measures

Measure	Lurasidone n=813 Participants lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment	529 participants

SECONDARY outcome

Timeframe: 24 weeks

The MADRS is a clinician-rated assessment of the subject's level of depression. Ten items are rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.

Outcome measures

Measure	Lurasidone n=813 Participants lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	-4.4 units on a scale Standard Deviation 10.60

SECONDARY outcome

Timeframe: 24 weeks

This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1="Normal, not ill" to 7="Very severly ill". Higher scores are associated with greater severity.

Outcome measures

Measure	Lurasidone n=813 Participants lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)	-0.58 units on a scale Standard Deviation 1.325

Adverse Events

Lurasidone

Serious events: 24 serious events

Other events: 246 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lurasidone n=813 participants at risk lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Gastrointestinal disorders Pancreatitis	0.12% 1/813 • Number of events 1 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
General disorders Disease Progression	0.12% 1/813 • Number of events 1 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Immune system disorders Hypersensitivity	0.12% 1/813 • Number of events 1 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Infections and infestations Appendicitis	0.12% 1/813 • Number of events 1 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Injury, poisoning and procedural complications Hand Fracture	0.12% 1/813 • Number of events 1 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Injury, poisoning and procedural complications Humerous Fracture	0.12% 1/813 • Number of events 1 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Injury, poisoning and procedural complications Radius Fracture	0.12% 1/813 • Number of events 1 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Injury, poisoning and procedural complications Road Traffic Accident	0.12% 1/813 • Number of events 1 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.12% 1/813 • Number of events 1 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip Neoplasm Malignant Stage Unspecified	0.12% 1/813 • Number of events 1 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Psychiatric disorders Completed Suicide	0.12% 1/813 • Number of events 1 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Psychiatric disorders Depression	0.74% 6/813 • Number of events 6 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Psychiatric disorders Depression Suicidal	0.25% 2/813 • Number of events 2 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Psychiatric disorders Major Depression	0.12% 1/813 • Number of events 1 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Psychiatric disorders Mania	0.25% 2/813 • Number of events 2 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Psychiatric disorders Suicidal Ideation	0.12% 1/813 • Number of events 1 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Psychiatric disorders Suicide Attempt	0.25% 2/813 • Number of events 2 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period

Other adverse events

Measure	Lurasidone n=813 participants at risk lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Gastrointestinal disorders Nausea	7.6% 62/813 • Number of events 90 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Nervous system disorders Akathisia	8.1% 66/813 • Number of events 84 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Nervous system disorders Headache	7.7% 63/813 • Number of events 76 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Nervous system disorders Parkinsonism	5.3% 43/813 • Number of events 54 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Psychiatric disorders Anxiety	5.8% 47/813 • Number of events 56 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period
Psychiatric disorders Insomnia	6.4% 52/813 • Number of events 60 • 24 Weeks January 22, 2009 - February 19, 2013 - recruitment period

Additional Information

Medical Director, CNS

Sunovion

Phone: 1-866-503-6351

Results disclosure agreements

• Principal investigator is a sponsor employee 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 following completion of study at all sites, the PI shall be free to publish.
• Publication restrictions are in place

Restriction type: OTHER