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Long-term Study of FK949E in Elderly Bipolar Disorder Patients | Clinical Trials | Clareo Health

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Long-term Study of FK949E in Elderly Bipolar Disorder Patients

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

NCT01737268•Astellas Pharma Inc

View on ClinicalTrials.gov

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

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (32)

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

Key Dates

Start Date

October 29, 2012

Primary Completion Date

June 29, 2016

Completion Date

June 29, 2016

Last Updated

November 19, 2024

Enrollment

ACTUAL participants

Conditions

Bipolar DisorderElderly

Interventions

FK949E

DRUG

Targeting Aging With a Ketone Ester for Function in Frailty

NCT06645847

Frail ElderlyAging+2 more

View study

RECRUITING

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Long-term Study of FK949E in Elderly Bipolar Disorder Patients

Inclusion Criteria

Exclusion Criteria

Targeting Aging With a Ketone Ester for Function in Frailty

University of Iowa Interventional Psychiatry Service Patient Registry

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