Clinical trial NCT01737268: Long-term Study of FK949E in Elderly Bipolar Disorder Patients
Official title: Long-term Study of FK949E in Elderly Patients -Long-term Study in Elderly Bipolar Disorder Patients With Major Depressive Episodes-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Elderly
Keywords: patients
Major depressive episode
FK949E
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary outcomes:
measure: Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)
timeFrame: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
measure: Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness
timeFrame: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
measure: Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression
timeFrame: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
measure: Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania
timeFrame: Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier)
measure: Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness
timeFrame: Week 52 (or the time of last assessment for participants who discontinued earlier)
measure: CGI-BP-C: Depression
timeFrame: Week 52 (or the time of last assessment for participants who discontinued earlier)
measure: CGI-BP-C: Mania
timeFrame: Week 52 (or the time of last assessment for participants who discontinued earlier)
measure: Number of Participants With Adverse Events
timeFrame: From first dose of study drug up to week 52 (52 weeks)
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Site JP00024
city: Fukuoka
country: Japan
facility: Site JP00023
city: Fukuoka
country: Japan
facility: Site JP00025
city: Fukushima
country: Japan
facility: Site JP00015
city: Fukushima
country: Japan
facility: Site JP00029
city: Hokkaido
country: Japan
facility: Site JP00001
city: Hokkaido
country: Japan
facility: Site JP00002
city: Hokkaido
country: Japan
facility: Site JP00003
city: Hokkaido
country: Japan
facility: Site JP00004
city: Hokkaido
country: Japan
facility: Site JP00005
city: Hokkaido
country: Japan
facility: Site JP00006
city: Hokkaido
country: Japan
facility: Site JP00007
city: Hokkaido
country: Japan
facility: Site JP00008
city: Hokkaido
country: Japan
facility: Site JP00009
city: Hokkaido
country: Japan
facility: Site JP00010
city: Hokkaido
country: Japan
facility: Site JP00011
city: Hokkaido
country: Japan
facility: Site JP00012
city: Hokkaido
country: Japan
facility: Site JP00013
city: Hyogo
country: Japan
facility: Site JP00028
city: Ibaraki
country: Japan
facility: Site JP00031
city: Kanagawa
country: Japan
facility: Site JP00017
city: Kanagawa
country: Japan
facility: Site JP00032
city: Kumamoto
country: Japan
facility: Site JP00019
city: Kyoto
country: Japan
facility: Site JP00018
city: Osaka
country: Japan
facility: Site JP00014
city: Tokyo
country: Japan
facility: Site JP00016
city: Tokyo
country: Japan
facility: Site JP00020
city: Tokyo
country: Japan
facility: Site JP00021
city: Tokyo
country: Japan
facility: Site JP00022
city: Tokyo
country: Japan
facility: Site JP00026
city: Tokyo
country: Japan
facility: Site JP00027
city: Tottori
country: Japan
facility: Site JP00030
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.