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Long-term Study of FK949E in Elderly Bipolar Disorder Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01737268
First received: November 8, 2012
Last updated: August 9, 2016
Last verified: August 2016
  Purpose
FK949E will be administered to elderly bipolar disorder patients with major depressive episode for 52 weeks. Its safety, efficacy, and plasma concentration change will be evaluated in an open-label manner.

Condition Intervention Phase
Bipolar Disorder
Elderly
Drug: FK949E
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Study of FK949E in Elderly Patients -Long-term Study in Elderly Bipolar Disorder Patients With Major Depressive Episodes-

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: Change from Baseline to 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HAM-D17 [ Time Frame: Change from Baseline to 52 weeks ] [ Designated as safety issue: No ]
    HAM-D (Hamilton Depression Scale)

  • Clinical Global Impression-Bipolar-Severity (CGI-BP-S) [ Time Frame: Change from Baseline to 52 weeks ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and Labo-tests [ Time Frame: for 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elderly patients
Orally administration
Drug: FK949E
oral
Other Name: quetiapine

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of bipolar I or II disorder as specified in the 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 is 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737268

Locations
Japan
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
Hyogo, 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
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More Information

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01737268     History of Changes
Other Study ID Numbers: 6949-CL-0022 
Study First Received: November 8, 2012
Last Updated: August 9, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
patients
Major depressive episode
FK949E

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016