Long-term Study of FK949E in Elderly Bipolar Disorder Patients

Phase 3

Completed

Conditions: Bipolar Disorder
Elderly

Interventions: Drug: FK949E

Registration Number: NCT01737268

Lead Sponsor: Astellas Pharma Inc

Brief Summary: FK949E was administered to elderly bipolar disorder patients with major depressive episode for 52 weeks. Its safety, efficacy, and plasma concentration change were evaluated in an open-label manner.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FK949E Elderly Participants	FK949E	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)	Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)	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.
Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression	Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)	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).
Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania	Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier)	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).
Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness	Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)	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).
Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness	Week 52 (or the time of last assessment for participants who discontinued earlier)	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.
CGI-BP-C: Depression	Week 52 (or the time of last assessment for participants who discontinued earlier)	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.
CGI-BP-C: Mania	Week 52 (or the time of last assessment for participants who discontinued earlier)	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.
Number of Participants With Adverse Events	From first dose of study drug up to week 52 (52 weeks)	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.

Trial Locations

Locations (32): Site JP00027
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Tokyo, Japan
Site JP00017
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Kanagawa, Japan
Site JP00021
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Tokyo, Japan
Site JP00024
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Chiba, Japan
Site JP00023
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Fukuoka, Japan
Site JP00031
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Ibaraki, Japan
Site JP00007
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Hokkaido, Japan
Site JP00009
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Hokkaido, Japan
Site JP00010
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Hokkaido, Japan
Site JP00015
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Fukushima, Japan
Site JP00025
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Fukuoka, Japan
Site JP00029
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Fukushima, Japan
Site JP00001
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Hokkaido, Japan
Site JP00002
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Hokkaido, Japan
Site JP00020
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Tokyo, Japan
Site JP00011
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Hokkaido, Japan
Site JP00018
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Kyoto, Japan
Site JP00028
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Hyogo, Japan
Site JP00022
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Tokyo, Japan
Site JP00030
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Tottori, Japan
Site JP00003
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Hokkaido, Japan
Site JP00006
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Hokkaido, Japan
Site JP00008
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Hokkaido, Japan
Site JP00016
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Tokyo, Japan
Site JP00014
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Osaka, Japan
Site JP00026
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Tokyo, Japan
Site JP00004
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Hokkaido, Japan
Site JP00005
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Hokkaido, Japan
Site JP00013
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Hokkaido, Japan
Site JP00032
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Kanagawa, Japan
Site JP00012
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Hokkaido, Japan
Site JP00019
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Kumamoto, Japan