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Long-term Study of FK949E in Elderly Bipolar Disorder Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737268
First Posted: November 29, 2012
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
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.

Condition Intervention Phase
Bipolar Disorder Elderly Drug: FK949E Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Study of FK949E in Elderly Patients -Long-term Study in Elderly Bipolar Disorder Patients With Major Depressive Episodes-

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: 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:
  • Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17) [ Time Frame: 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 Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness [ Time Frame: 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: Depression [ Time Frame: 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 Hamilton Depression Scale (HAM-D17) in CGI-BP-S: Mania [ Time Frame: 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).

  • Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 20
Actual Study Start Date: October 29, 2012
Study Completion Date: June 29, 2016
Primary Completion Date: June 29, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: FK949E
Oral tablet
Other Name: quetiapine

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737268


Locations
Japan
Site JP00024
Chiba, Japan
Site JP00023
Fukuoka, Japan
Site JP00025
Fukuoka, Japan
Site JP00015
Fukushima, Japan
Site JP00029
Fukushima, Japan
Site JP00001
Hokkaido, Japan
Site JP00002
Hokkaido, Japan
Site JP00003
Hokkaido, Japan
Site JP00004
Hokkaido, Japan
Site JP00005
Hokkaido, Japan
Site JP00006
Hokkaido, Japan
Site JP00007
Hokkaido, Japan
Site JP00008
Hokkaido, Japan
Site JP00009
Hokkaido, Japan
Site JP00010
Hokkaido, Japan
Site JP00011
Hokkaido, Japan
Site JP00012
Hokkaido, Japan
Site JP00013
Hokkaido, Japan
Site JP00028
Hyogo, Japan
Site JP00031
Ibaraki, Japan
Site JP00017
Kanagawa, Japan
Site JP00032
Kanagawa, Japan
Site JP00019
Kumamoto, Japan
Site JP00018
Kyoto, Japan
Site JP00014
Osaka, Japan
Site JP00016
Tokyo, Japan
Site JP00020
Tokyo, Japan
Site JP00021
Tokyo, Japan
Site JP00022
Tokyo, Japan
Site JP00026
Tokyo, Japan
Site JP00027
Tokyo, Japan
Site JP00030
Tottori, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More Information

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01737268     History of Changes
Other Study ID Numbers: 6949-CL-0022
First Submitted: November 8, 2012
First Posted: November 29, 2012
Results First Submitted: June 15, 2017
Results First Posted: October 31, 2017
Last Update Posted: October 31, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
patients
Major depressive episode
FK949E

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders