Long-term Study of FK949E in Elderly Bipolar Disorder Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Bipolar Disorder, Elderly

Intervention / Treatment
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* Drug: FK949E


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FK949E Elderly Participants<br>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. | Drug: FK949E<br>* Oral tablet<br>* Other names: quetiapine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patients, Major depressive episode, FK949E