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Long-term Study of FK949E in Elderly Bipolar Disorder Patients

Primary Purpose

Bipolar Disorder, Elderly

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
FK949E
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring patients, Major depressive episode, FK949E

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site JP00024
  • Site JP00023
  • Site JP00025
  • Site JP00015
  • Site JP00029
  • Site JP00001
  • Site JP00002
  • Site JP00003
  • Site JP00004
  • Site JP00005
  • Site JP00006
  • Site JP00007
  • Site JP00008
  • Site JP00009
  • Site JP00010
  • Site JP00011
  • Site JP00012
  • Site JP00013
  • Site JP00028
  • Site JP00031
  • Site JP00017
  • Site JP00032
  • Site JP00019
  • Site JP00018
  • Site JP00014
  • Site JP00016
  • Site JP00020
  • Site JP00021
  • Site JP00022
  • Site JP00026
  • Site JP00027
  • Site JP00030

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FK949E Elderly Participants

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 8, 2012
Last Updated
January 10, 2019
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01737268
Brief Title
Long-term Study of FK949E in Elderly Bipolar Disorder Patients
Official Title
Long-term Study of FK949E in Elderly Patients -Long-term Study in Elderly Bipolar Disorder Patients With Major Depressive Episodes-
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 29, 2012 (Actual)
Primary Completion Date
June 29, 2016 (Actual)
Study Completion Date
June 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Elderly
Keywords
patients, Major depressive episode, FK949E

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FK949E Elderly Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
FK949E
Other Intervention Name(s)
quetiapine
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description
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.
Time Frame
Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary Outcome Measure Information:
Title
Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)
Description
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.
Time Frame
Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Title
Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness
Description
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).
Time Frame
Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Title
Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression
Description
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).
Time Frame
Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Title
Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania
Description
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).
Time Frame
Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier)
Title
Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness
Description
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.
Time Frame
Week 52 (or the time of last assessment for participants who discontinued earlier)
Title
CGI-BP-C: Depression
Description
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.
Time Frame
Week 52 (or the time of last assessment for participants who discontinued earlier)
Title
CGI-BP-C: Mania
Description
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.
Time Frame
Week 52 (or the time of last assessment for participants who discontinued earlier)
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
From first dose of study drug up to week 52 (52 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
Facility Name
Site JP00024
City
Chiba
Country
Japan
Facility Name
Site JP00023
City
Fukuoka
Country
Japan
Facility Name
Site JP00025
City
Fukuoka
Country
Japan
Facility Name
Site JP00015
City
Fukushima
Country
Japan
Facility Name
Site JP00029
City
Fukushima
Country
Japan
Facility Name
Site JP00001
City
Hokkaido
Country
Japan
Facility Name
Site JP00002
City
Hokkaido
Country
Japan
Facility Name
Site JP00003
City
Hokkaido
Country
Japan
Facility Name
Site JP00004
City
Hokkaido
Country
Japan
Facility Name
Site JP00005
City
Hokkaido
Country
Japan
Facility Name
Site JP00006
City
Hokkaido
Country
Japan
Facility Name
Site JP00007
City
Hokkaido
Country
Japan
Facility Name
Site JP00008
City
Hokkaido
Country
Japan
Facility Name
Site JP00009
City
Hokkaido
Country
Japan
Facility Name
Site JP00010
City
Hokkaido
Country
Japan
Facility Name
Site JP00011
City
Hokkaido
Country
Japan
Facility Name
Site JP00012
City
Hokkaido
Country
Japan
Facility Name
Site JP00013
City
Hokkaido
Country
Japan
Facility Name
Site JP00028
City
Hyogo
Country
Japan
Facility Name
Site JP00031
City
Ibaraki
Country
Japan
Facility Name
Site JP00017
City
Kanagawa
Country
Japan
Facility Name
Site JP00032
City
Kanagawa
Country
Japan
Facility Name
Site JP00019
City
Kumamoto
Country
Japan
Facility Name
Site JP00018
City
Kyoto
Country
Japan
Facility Name
Site JP00014
City
Osaka
Country
Japan
Facility Name
Site JP00016
City
Tokyo
Country
Japan
Facility Name
Site JP00020
City
Tokyo
Country
Japan
Facility Name
Site JP00021
City
Tokyo
Country
Japan
Facility Name
Site JP00022
City
Tokyo
Country
Japan
Facility Name
Site JP00026
City
Tokyo
Country
Japan
Facility Name
Site JP00027
City
Tokyo
Country
Japan
Facility Name
Site JP00030
City
Tottori
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Citations:
PubMed Identifier
32792252
Citation
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.
Results Reference
derived
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=214
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

Long-term Study of FK949E in Elderly Bipolar Disorder Patients

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