Long-term Study of FK949E in Elderly Bipolar Disorder Patients

NCT ID: NCT01737268

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-29
• Study Completion Date: 2016-06-29

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.

Conditions

Bipolar Disorder; Elderly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FK949E

Intervention Type: DRUG

Oral tablet

Interventions

FK949E

Oral tablet

Intervention Type: DRUG

Other Intervention Names

quetiapine

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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

Hyōgo, , 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

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 32792252 (View on PubMed)

Related Links

https://www.astellasclinicalstudyresults.com/study.aspx?ID=214

Link to results on Astellas Clinical Study Results website

Other Identifiers

6949-CL-0022

Identifier Type: -

Identifier Source: org_study_id