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Bipolar DisorderPhase 3NCT01737268

Long-term Study of FK949E in Elderly Bipolar Disorder Patients

A Phase 3 study testing FK949E in people with Bipolar Disorder and Elderly, run by Astellas Pharma Inc at 32 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Bipolar Disorder, Elderly
What is being tested?
FK949E
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
32 sitesJapan
Study dates
29 Oct 2012to 29 Jun 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Japan32 sites

  • Site JP00024

    Chiba

  • Site JP00023

    Fukuoka

  • Site JP00025

    Fukuoka

  • Site JP00015

    Fukushima

  • Site JP00029

    Fukushima

  • Site JP00001

    Hokkaido

  • Site JP00002

    Hokkaido

  • Site JP00003

    Hokkaido

  • Site JP00004

    Hokkaido

  • Site JP00005

    Hokkaido

  • Site JP00006

    Hokkaido

  • Site JP00007

    Hokkaido

  • Site JP00008

    Hokkaido

  • Site JP00009

    Hokkaido

  • Site JP00010

    Hokkaido

  • Site JP00011

    Hokkaido

  • Site JP00012

    Hokkaido

  • Site JP00013

    Hokkaido

  • Site JP00028

    Hyōgo

  • Site JP00031

    Ibaraki

  • Site JP00017

    Kanagawa

  • Site JP00032

    Kanagawa

  • Site JP00019

    Kumamoto

  • Site JP00018

    Kyoto

  • Site JP00014

    Osaka

  • Site JP00016

    Tokyo

  • Site JP00020

    Tokyo

  • Site JP00021

    Tokyo

  • Site JP00022

    Tokyo

  • Site JP00026

    Tokyo

  • Site JP00027

    Tokyo

  • Site JP00030

    Tottori

Other trials in Japan

About this study

Official title: Long-term Study of FK949E in Elderly Patients -Long-term Study in Elderly Bipolar Disorder Patients With Major Depressive Episodes-

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.

Being tested
FK949E
Keywords
patients, Major depressive episode, FK949E
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FK949EDrug

    Also called quetiapine

    Oral tablet

Study groups in NCT01737268
Study groupRoleWhat they receive
FK949E Elderly ParticipantsExperimentalAfter 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.
Receives: Drug: FK949E

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)

  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.

    Measured: 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).

    Measured: 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).

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2012 (estimated)
  2. Study start29 Oct 2012
  3. Primary completion29 Jun 2016
  4. Study completion29 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01737268
Sponsor's protocol ID
6949-CL-0022
Status last verified
Oct 2024
First submitted
8 Nov 2012
Last updated
19 Nov 2024
Data monitoring committee
No
Individual data sharing
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/.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FK949E in people with Bipolar Disorder and Elderly, run by Astellas Pharma Inc at 32 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01737268, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.

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