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CompletedNCT01737268Updated Nov 19, 2024Results posted

Long-term Study of FK949E in Elderly Bipolar Disorder Patients

A Phase 3 interventional study of FK949E in Bipolar Disorder and Elderly, sponsored by Astellas Pharma Inc. Completed at 32 sites in Japan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-11-19.

Sponsored by Astellas Pharma Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bipolar Disorder
  • Elderly

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Keywords

  • patients
  • Major depressive episode
  • FK949E
03

In context

Bipolar Disorder

1,602 studies on the registry are indexed under Bipolar Disorder; 255 are open to participants now.

This study's enrollment of 20 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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

Interventions

  • DrugFK949E

    Oral tablet

    Also known as: quetiapine

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

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

  2. 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).

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

  3. 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).

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

  4. 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).

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

07

Results

Posted Oct 31, 2017

Participant flow

Elderly participants with documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision criteria for bipolar I disorder or bipolar II disorder, with most recent episode depressed confirmed by the Mini-International Neuropsychiatric Interview were recruited from 32 sites in Japan.

Participant flow — Overall Study
MilestoneFK949E Elderly Participants
Started20
Treated20
Completed11
Not completed9
Withdrew: Adverse event6
Withdrew: Worsening of target disease2
Withdrew: In consideration of the patient's safety1

Outcome measures

PrimaryChange 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.

Time frame:
Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Reported as:
Mean · units on a scale
Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
units on a scaleFK949E Elderly Participants
Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score-13.1 ± 11.0
SecondaryChange 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.

Time frame:
Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Reported as:
Mean · units on a scale
Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)
units on a scaleFK949E Elderly Participants
Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)-10.5 ± 8.2
SecondaryChange 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).

Time frame:
Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Reported as:
Mean · units on a scale
Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness
units on a scaleFK949E Elderly Participants
Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness-1.2 ± 1.5
SecondaryChange 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).

Time frame:
Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Reported as:
Mean · units on a scale
Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression
units on a scaleFK949E Elderly Participants
Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression-1.3 ± 1.5
SecondaryChange 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).

Time frame:
Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier)
Reported as:
Mean · units on a scale
Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania
units on a scaleFK949E Elderly Participants
Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania0 ± 0
SecondaryClinical 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.

Time frame:
Week 52 (or the time of last assessment for participants who discontinued earlier)
Reported as:
Mean · units on a scale
Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness
units on a scaleFK949E Elderly Participants
Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness2.4 ± 1.3
SecondaryCGI-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.

Time frame:
Week 52 (or the time of last assessment for participants who discontinued earlier)
Reported as:
Mean · units on a scale
CGI-BP-C: Depression
units on a scaleFK949E Elderly Participant
CGI-BP-C: Depression2.4 ± 1.3
SecondaryCGI-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.

Time frame:
Week 52 (or the time of last assessment for participants who discontinued earlier)
Reported as:
Mean · units on a scale
CGI-BP-C: Mania
units on a scaleFK949E Elderly Participants
CGI-BP-C: Mania4.0 ± 0.0
SecondaryNumber 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.

Time frame:
From first dose of study drug up to week 52 (52 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events
ParticipantsFK949E Elderly Participants
Any AE18
Drug-related AEs18
Deaths0
Serious AEs2
Drug-related SAEs1
AEs that caused study drug discountinuation8
Drug-related AEs that caused study drug discont.7

Adverse events

Collected over From first dose of study drug up to week 52 (52 weeks). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
FK949E Elderly Participants0/20 (0%)2/20 (10%)18/20 (90%)
Most frequent serious events
Most frequent serious events
EventFK949E Elderly Participants
MalaiseGeneral disorders1/20
DepressionPsychiatric disorders1/20
Most frequent other events
Showing 10 of 37
Most frequent other events
EventFK949E Elderly Participants
SomnolenceNervous system disorders11/20
ThirstGeneral disorders7/20
NasopharyngitisInfections and infestations4/20
Blood prolactin increasedInvestigations4/20
DizzinessNervous system disorders4/20
MalaiseGeneral disorders3/20
NauseaGastrointestinal disorders2/20
Blood thyroid stimulating hormone increasedInvestigations2/20
HeadacheNervous system disorders2/20
Gait disturbanceGeneral disorders2/20

Baseline characteristics

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.

Age, Continuous
Age, Continuous(Years)FK949E Elderly Participants
Mean70.9 ± 5.3
Sex: Female, Male
Sex: Female, Male(Participants)FK949E Elderly Participants
Female11
Male8
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Units of a scale)FK949E Elderly Participants
Mean25.1 ± 6.4
Hamilton Depression Scale (HAM-D17) Total Score
Hamilton Depression Scale (HAM-D17) Total Score(Units of a scale)FK949E Elderly Participants
Mean19.3 ± 4.9
08

Study locations

32 sites
  • 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
09

References and documents

Publications

  • 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. PubMed 32792252 ↗

Individual participant data

Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01737268
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Nov 29, 2012
Start date
Oct 29, 2012
Primary completion
Jun 29, 2016
Completion
Jun 29, 2016
Results posted
Oct 31, 2017
Last update
Nov 19, 2024

Study contacts

Medical Director
study director · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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