Long-term Study of FK949E in Elderly Bipolar Disorder Pat... | NCT01737268

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Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FK949E Elderly Participants	Experimental	After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.	Drug: FK949E

Name	Type	Description	Arm Group Labels	Other Names
FK949E	Drug	Oral tablet	FK949E Elderly Participants	quetiapine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.	Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)	The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 with lower scores indicating less depressive symptoms.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of bipolar I or II disorder as specified in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR), with a major depressive episode
Able to participate in the study with understanding of and compliance with subject requirements during the study in the investigator's or subinvestigator's opinion
Male subjects must agree to take appropriate contraceptive measures with condoms during the study period.
Female subjects must be confirmed to have no childbearing potential during the study period

Exclusion Criteria:

Concurrent or previous history of DSM-IV-TR Axis I disorders, except bipolar disorder, within the last 6 months before informed consent
Concurrence of DSM-IV-TR Axis II disorder that was considered to greatly affect patient's current mental status.
The Young Mania Rating Scale (YMRS) total score of 13 points or more.
Nine or more mood episodes within the last 12 months before informed consent.
Lack of response to at least 6-week treatment with at least 2 antidepressants for the current major depressive episode in the investigator's or subinvestigator's opinion
The current major depressive episode persisting for more than 12 months or less than 4 weeks before informed consent.
History of substance dependence (other than caffeine and nicotine) or alcohol abuse or dependence.
Treatment with a depot antipsychotic within the last 49 days before primary registration.
Unable to suspend antipsychotics or antidepressants after primary registration
Treatment with two or more of mood stabilizers (lithium carbonate and/or sodium valproate) and lamotrigine, if these drugs, except one of either drug, cannot be suspended after primary registration.
Unable to suspend antiepileptics (except lamotrigine and sodium valproate), antianxiety agents, hypnotics, sedatives, psychostimulants, antiparkinsonian agents, cerebral ameliorators, antidementia agents, or anorectics, except those specified as conditionally-allowed concomitant drugs, from 7 days before primary registration
Electroconvulsive therapy within the last 83 days before primary registration.
A possible need of psychotherapy during the study period (unless the therapy has been commenced at least 83 days before primary registration).
The Hamilton Depression Rating Scale (HAM-D17) suicide score of 3 points or more, history of suicide attempt within the last 6 months before informed consent, or the risk of suicide in the investigator's or subinvestigator's opinion

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Astellas Pharma Inc	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site JP00024		Chiba			Japan
Site JP00023

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32792252	Derived	Fukushi R, Nomura Y, Katashima M, Komatsu K, Sato Y, Takada A. Approach to Evaluating QT Prolongation of Quetiapine Fumarate in Late Stage of Clinical Development Using Concentration-QTc Modeling and Simulation in Japanese Patients With Bipolar Disorder. Clin Ther. 2020 Aug;42(8):1483-1493.e1. doi: 10.1016/j.clinthera.2020.06.002. Epub 2020 Aug 11.

Label	URL
Link to results on Astellas Clinical Study Results website	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	FK949E Elderly Participants	After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Full Analysis Set (FAS), which consisted of participants who received at least one dose of the study drug and were evaluated for at least one efficacy variable after the start of treatment with the study drug.

Arm/Group Information

ID	Title	Description
BG000	FK949E Elderly Participants	After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.

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
	BG00070.9± 5.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00011
Male	BG0008

Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.

FAS

Mean

Standard Deviation

Units of a scale

Title

Denominators

Categories

Title	Measurements
	BG00025.1± 6.4

Hamilton Depression Scale (HAM-D17) Total Score

The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 with lower scores indicating less depressive symptoms.

FAS

Mean

Standard Deviation

Units of a scale

Title

Denominators

Categories

Title	Measurements
	BG00019.3± 4.9

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

Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

FAS population; last assessment value is used for participants who discontinued before week 52.

Posted

Mean

Standard Deviation

units on a scale

Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)

ID	Title	Description
OG000	FK949E Elderly Participants	After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.

Units	Counts
Participants	OG00019

Title

Denominators

Categories

Title	Measurements
	OG000-13.1± 11.0

Secondary

Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)

FAS population; last assessment value is used for participants who discontinued before week 52.

Posted

Mean

Standard Deviation

units on a scale

Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)

ID	Title	Description
OG000	FK949E Elderly Participants	After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.

Units	Counts
Participants

Secondary

Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).

FAS population; last assessment value is used for participants who discontinued before week 52.

Posted

Mean

Standard Deviation

units on a scale

Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)

ID	Title	Description
OG000	FK949E Elderly Participants	After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.

Units	Counts
Participants

Secondary

Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression

FAS population; last assessment value is used for participants who discontinued before week 52.

Posted

Mean

Standard Deviation

units on a scale

Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)

ID	Title	Description
OG000	FK949E Elderly Participants	After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.

Units	Counts
Participants

Secondary

Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania

FAS population; last assessment value is used for participants who discontinued before week 52.

Posted

Mean

Standard Deviation

units on a scale

Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier)

ID	Title	Description
OG000	FK949E Elderly Participants	After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.

Units	Counts
Participants

Secondary

Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.

FAS population; last assessment value is used for participants who discontinued before week 52.

Posted

Mean

Standard Deviation

units on a scale

Week 52 (or the time of last assessment for participants who discontinued earlier)

ID	Title	Description
OG000	FK949E Elderly Participants	After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.

Units	Counts
Participants

Secondary

CGI-BP-C: Depression

FAS population; last assessment value is used for participants who discontinued before week 52.

Posted

Mean

Standard Deviation

units on a scale

Week 52 (or the time of last assessment for participants who discontinued earlier)

ID	Title	Description
OG000	FK949E Elderly Participant	After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period

Units	Counts
Participants

Secondary

CGI-BP-C: Mania

FAS population; last assessment value is used for participants who discontinued before week 52.

Posted

Mean

Standard Deviation

units on a scale

Week 52 (or the time of last assessment for participants who discontinued earlier)

ID	Title	Description
OG000	FK949E Elderly Participants	After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.

Units	Counts
Participants

Secondary

Number of Participants With Adverse Events

An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, re quire d or prolonged hospitalization or was considered medically important.

Safely Analysis Set (SAF), which included participants who received at least one dose of study drug.

Posted

Count of Participants

Participants

From first dose of study drug up to week 52 (52 weeks)

ID	Title	Description
OG000	FK949E Elderly Participants	After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.

Units	Counts

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	FK949E Elderly Participants	After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.	0	20	2	20	18	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Malaise	General disorders	MedDRA/J v18.0			EG0001 affected20 at risk
Depression	Psychiatric disorders	MedDRA/J v18.0			EG0001 affected20 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Hypothyroidism	Endocrine disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Constipation	Gastrointestinal disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Gastritis	Gastrointestinal disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Nausea	Gastrointestinal disorders	MedDRA/J v18.0	EG0002 affected20 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Fatigue	General disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Malaise	General disorders	MedDRA/J v18.0	EG0003 affected20 at risk
Thirst	General disorders	MedDRA/J v18.0	EG0007 affected20 at risk
Influenza	Infections and infestations	MedDRA/J v18.0	EG0001 affected20 at risk
Nasopharyngitis	Infections and infestations	MedDRA/J v18.0	EG0004 affected20 at risk
Fall	Injury, poisoning and procedural complications	MedDRA/J v18.0	EG0001 affected20 at risk
Wound	Injury, poisoning and procedural complications	MedDRA/J v18.0	EG0001 affected20 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA/J v18.0	EG0001 affected20 at risk
Blood glucose decreased	Investigations	MedDRA/J v18.0	EG0001 affected20 at risk
Blood prolactin increased	Investigations	MedDRA/J v18.0	EG0004 affected20 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA/J v18.0	EG0002 affected20 at risk
Blood triglycerides increased	Investigations	MedDRA/J v18.0	EG0001 affected20 at risk
Blood uric acid increased	Investigations	MedDRA/J v18.0	EG0001 affected20 at risk
Liver function test abnormal	Investigations	MedDRA/J v18.0	EG0001 affected20 at risk
Weight decreased	Investigations	MedDRA/J v18.0	EG0001 affected20 at risk
Platelet count increased	Investigations	MedDRA/J v18.0	EG0001 affected20 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Dizziness	Nervous system disorders	MedDRA/J v18.0	EG0004 affected20 at risk
Dizziness postural	Nervous system disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Dysarthria	Nervous system disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Dysgeusia	Nervous system disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Headache	Nervous system disorders	MedDRA/J v18.0	EG0002 affected20 at risk
Movement disorder	Nervous system disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Somnolence	Nervous system disorders	MedDRA/J v18.0	EG00011 affected20 at risk
Depression	Psychiatric disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Intentional self-injury	Psychiatric disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Hypertension	Vascular disorders	MedDRA/J v18.0	EG0001 affected20 at risk
Gait disturbance	General disorders	MedDRA/J v18.0	EG0002 affected20 at risk

ID	Term
D001714	Bipolar Disorder

ID	Term
D000069348	Quetiapine Fumarate

Ancestor Terms

ID	Term
D003987	Dibenzothiazepines
D013841	Thiazepines
D013846	Thiepins
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders