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Long-term Study of FK949E in Elderly Bipolar Disorder Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737268
First Posted: November 29, 2012
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
Results First Submitted: June 15, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Bipolar Disorder
Elderly
Intervention: Drug: FK949E

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Elderly participants with documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision criteria for bipolar I disorder or bipolar II disorder, with most recent episode depressed confirmed by the Mini-International Neuropsychiatric Interview were recruited from 32 sites in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who were not taking quetiapine or was at < 50 mg/day at least 28 days prior to informed consent, FK949E was administered at an initial dose of 50 mg during the dose-titration period. Participants who were taking quetiapine at 50 to < 300 mg/day or 300 mg/day, FK949E was administered at 150 mg/day during the dose-titration period.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    FK949E Elderly Participants
STARTED   20 
Treated   20 
COMPLETED   11 
NOT COMPLETED   9 
Adverse Event                6 
Worsening of Target Disease                2 
In consideration of the patient’s safety                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), which consisted of participants who received at least one dose of the study drug and were evaluated for at least one efficacy variable after the start of treatment with the study drug.

Reporting Groups
  Description
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.

Baseline Measures
   FK949E Elderly Participants 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.9  (5.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  57.9% 
Male      8  42.1% 
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [1] [2] 
[Units: Units of a scale]
Mean (Standard Deviation)
 25.1  (6.4) 
[1] 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.
[2] FAS
Hamilton Depression Scale (HAM-D17) Total Score [1] [2] 
[Units: Units of a scale]
Mean (Standard Deviation)
 19.3  (4.9) 
[1] The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 with lower scores indicating less depressive symptoms.
[2] FAS


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier) ]

2.  Secondary:   Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)   [ Time Frame: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier) ]

3.  Secondary:   Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness   [ Time Frame: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier) ]

4.  Secondary:   Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression   [ Time Frame: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier) ]

5.  Secondary:   Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17) in CGI-BP-S: Mania   [ Time Frame: Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier) ]

6.  Secondary:   Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness   [ Time Frame: Week 52 (or the time of last assessment for participants who discontinued earlier) ]

7.  Secondary:   CGI-BP-C: Depression   [ Time Frame: Week 52 (or the time of last assessment for participants who discontinued earlier) ]

8.  Secondary:   CGI-BP-C: Mania   [ Time Frame: Week 52 (or the time of last assessment for participants who discontinued earlier) ]

9.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: From first dose of study drug up to week 52 (52 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice-President, Japan-Asia Clinical Development Administration
Organization: Astellas Pharma Inc.
phone: +81-3-3244-0512
e-mail: Astellas.resultsdisclosure@astellas.com



Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01737268     History of Changes
Other Study ID Numbers: 6949-CL-0022
First Submitted: November 8, 2012
First Posted: November 29, 2012
Results First Submitted: June 15, 2017
Results First Posted: October 31, 2017
Last Update Posted: October 31, 2017