NCT01737268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2012

Typical duration for phase_3

Geographic Reach
1 country

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 31, 2017

Completed
Last Updated

November 19, 2024

Status Verified

October 1, 2024

Enrollment Period

3.7 years

First QC Date

November 8, 2012

Results QC Date

June 15, 2017

Last Update Submit

October 25, 2024

Conditions

Bipolar DisorderElderly

Keywords

patientsMajor depressive episodeFK949E

Outcome Measures

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.

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

Secondary Outcomes (8)

  • 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)

  • 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)

  • 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)

  • 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)

  • Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness

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

  • +3 more secondary outcomes

Study Arms (1)

FK949E Elderly Participants

EXPERIMENTAL

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

FK949EDRUG

Oral tablet

Also known as: quetiapine
FK949E Elderly Participants

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Site JP00024

Chiba, Japan

Location

Site JP00023

Fukuoka, Japan

Location

Site JP00025

Fukuoka, Japan

Location

Site JP00015

Fukushima, Japan

Location

Site JP00029

Fukushima, Japan

Location

Site JP00001

Hokkaido, Japan

Location

Site JP00002

Hokkaido, Japan

Location

Site JP00003

Hokkaido, Japan

Location

Site JP00004

Hokkaido, Japan

Location

Site JP00005

Hokkaido, Japan

Location

Site JP00006

Hokkaido, Japan

Location

Site JP00007

Hokkaido, Japan

Location

Site JP00008

Hokkaido, Japan

Location

Site JP00009

Hokkaido, Japan

Location

Site JP00010

Hokkaido, Japan

Location

Site JP00011

Hokkaido, Japan

Location

Site JP00012

Hokkaido, Japan

Location

Site JP00013

Hokkaido, Japan

Location

Site JP00028

Hyōgo, Japan

Location

Site JP00031

Ibaraki, Japan

Location

Site JP00017

Kanagawa, Japan

Location

Site JP00032

Kanagawa, Japan

Location

Site JP00019

Kumamoto, Japan

Location

Site JP00018

Kyoto, Japan

Location

Site JP00014

Osaka, Japan

Location

Site JP00016

Tokyo, Japan

Location

Site JP00020

Tokyo, Japan

Location

Site JP00021

Tokyo, Japan

Location

Site JP00022

Tokyo, Japan

Location

Site JP00026

Tokyo, Japan

Location

Site JP00027

Tokyo, Japan

Location

Site JP00030

Tottori, Japan

Location

Related Publications (1)

  • 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.

    PMID: 32792252DERIVED

Related Links

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Vice-President, Japan-Asia Clinical Development Administration
Organization
Astellas Pharma Inc.
Astellas.resultsdisclosure@astellas.com
+81-3-3244-0512

Study Officials

  • Medical Director

    Astellas Pharma Inc

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2012

First Posted

November 29, 2012

Study Start

October 29, 2012

Primary Completion

June 29, 2016

Study Completion

June 29, 2016

Last Updated

November 19, 2024

Results First Posted

October 31, 2017

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

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/.

Locations

JP(32)