Lurasidone - A 24-week Extension Study of Patients With B... | NCT00868959

ID	Type	Description	Link
EUDRACT No. 2008-007483-42

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
lurasidone	Experimental		Drug: lurasidone

Name	Type	Description	Arm Group Labels	Other Names
lurasidone	Drug	Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks	lurasidone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment	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)	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Director, MD	Sumitomo Pharma America, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Woodland International Research Inc		Little Rock	Arkansas	72211	United States
South Coast Clinical Trials Inc.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29146409	Derived	Forester BP, Sajatovic M, Tsai J, Pikalov A, Cucchiaro J, Loebel A. Safety and Effectiveness of Long-Term Treatment with Lurasidone in Older Adults with Bipolar Depression: Post-Hoc Analysis of a 6-Month, Open-Label Study. Am J Geriatr Psychiatry. 2018 Feb;26(2):150-159. doi: 10.1016/j.jagp.2017.08.013. Epub 2017 Oct 10.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Lurasidone	lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00042.7± 12.03

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0006
Between 18 and 65 years	BG000790

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000427
Male	BG000386

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000283

Slovakia

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment

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)

Posted

Number

participants

24 weeks

ID	Title	Description
OG000	Lurasidone	lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks

Units	Counts
Participants	OG000813

Title

Denominators

Categories

Title	Measurements
	OG000529

Secondary

Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

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.

Posted

Mean

Standard Deviation

units on a scale

24 weeks

ID	Title	Description
OG000	Lurasidone	lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks

Units	Counts
Participants	OG000

Secondary

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)

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.

Posted

Mean

Standard Deviation

units on a scale

24 weeks

ID	Title	Description
OG000	Lurasidone	lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks

Units	Counts
Participants	OG000813

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lurasidone	lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks			24	813	246	813

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pancreatitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected813 at risk
Disease Progression	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected813 at risk
Hypersensitivity	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected813 at risk
Appendicitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected813 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected813 at risk
Humerous Fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected813 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected813 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected813 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected813 at risk
Lip Neoplasm Malignant Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected813 at risk
Completed Suicide	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected813 at risk
Depression	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected813 at risk
Depression Suicidal	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected813 at risk
Major Depression	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected813 at risk
Mania	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected813 at risk
Suicidal Ideation	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected813 at risk
Suicide Attempt	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected813 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG00090 events62 affected813 at risk
Akathisia	Nervous system disorders	MedDRA (14.1)	Systematic Assessment	EG00084 events66 affected813 at risk
Headache	Nervous system disorders	MedDRA (14.1)	Systematic Assessment	EG00076 events63 affected813 at risk
Parkinsonism	Nervous system disorders	MedDRA (14.1)	Systematic Assessment	EG00054 events43 affected813 at risk
Anxiety	Psychiatric disorders	MedDRA (14.1)	Systematic Assessment	EG00056 events47 affected813 at risk
Insomnia	Psychiatric disorders	MedDRA (14.1)	Systematic Assessment	EG00060 events52 affected813 at risk

Ancestor Terms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior