Long-term Study of FK949E in Elderly Bipolar Disorder Patients

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737268
• Other study ID #: 6949-CL-0022
• Status: Completed
• Phase: Phase 3
• Start date: October 29, 2012
• Est. completion date: June 29, 2016

Study information

• Verified date: January 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 29, 2016
• Est. primary completion date: June 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Elderly

Intervention

Drug:
• FK949E
Oral tablet

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	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.	Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary	Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)	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.	Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary	Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness	The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).	Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary	Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression	The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).	Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary	Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania	The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).	Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary	Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness	The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.	Week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary	CGI-BP-C: Depression	The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.	Week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary	CGI-BP-C: Mania	The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.	Week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary	Number of Participants With Adverse Events	An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, re quire d or prolonged hospitalization or was considered medically important.	From first dose of study drug up to week 52 (52 weeks)

External Links

•   Link to results on Astellas Clinical Study Results website