Back to resultsStudy to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
Primary Purpose
Bipolar Depression
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
FK949E
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Depression focused on measuring major depressive episodes, FK949E, quetiapine, bipolar depression, bipolar disorder
Eligibility Criteria
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.
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 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 the start of the pre-treatment observation period.
- Unable to suspend antipsychotics or antidepressants after the start of the pre-treatment observation period.
- Treatment with more than one of the following three drugs, mood stabilizers (lithium carbonate and/or sodium valproate) and lamotrigine, if these drugs, except one of either drugs, cannot be suspended after the start of the pre-treatment observation period.
- 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 the start of the pre-treatment observation period.
- Unable to suspend CYP3A4 inhibitors or inducers, or monoamine oxidase (MAO) inhibitors from 7 days before the start of the pre-treatment observation period.
- Electroconvulsive therapy within the last 83 days before the start of the pre-treatment observation period.
- A possible need of psychotherapy during the study period (unless the therapy has been commenced at least 83 days before the start of the pre-treatment observation period).
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
FK949E 50 MG / FK949E 150 MG
FK949E 150 MG / FK949E 50 MG
Arm Description
Participants who received the 50 mg tablet once daily during Treatment Period II (8 weeks) and 150 mg tablet once daily during Treatment Period III (8 weeks).
Participants who received the 150 mg tablet once daily during Treatment Period II (8 weeks) and 50 mg tablet once daily during Treatment Period III (8 weeks).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Clinical Global Impression-Bipolar-Severity of Illness (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).
Clinical Global Impression-Bipolar-Severity of Illness (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)
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.
Clinical Global Impression-Bipolar-Change (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.
Clinical Global Impression-Bipolar-Change (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.
Number of Participants With Adverse Events
An adverse event (AE) is defined as any undesirable or unintended sign (including abnonmal 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, required or prolonged hospitalization or was considered medically important.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02362412
Brief Title
Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
Official Title
Study of FK949E - An Open-label, Two-way Crossover Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 18, 2015 (Actual)
Primary Completion Date
February 6, 2016 (Actual)
Study Completion Date
February 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet at the equivalent total daily dose in bipolar disorder patients with major depressive episodes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
major depressive episodes, FK949E, quetiapine, bipolar depression, bipolar disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FK949E 50 MG / FK949E 150 MG
Arm Type
Experimental
Arm Description
Participants who received the 50 mg tablet once daily during Treatment Period II (8 weeks) and 150 mg tablet once daily during Treatment Period III (8 weeks).
Arm Title
FK949E 150 MG / FK949E 50 MG
Arm Type
Experimental
Arm Description
Participants who received the 150 mg tablet once daily during Treatment Period II (8 weeks) and 50 mg tablet once daily during Treatment Period III (8 weeks).
Intervention Type
Drug
Intervention Name(s)
FK949E
Other Intervention Name(s)
quetiapine
Intervention Description
A tablet containing 50 mg or 150 mg of quetiapine taken orally.
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description
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.
Time Frame
Week 8 of each treatment period (Week 12 and Week 20)
Secondary Outcome Measure Information:
Title
Hamilton Depression Scale (HAM-D17)
Description
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.
Time Frame
Week 8 of each treatment period (Week 12 and Week 20)
Title
Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness
Description
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).
Time Frame
Week 8 of each treatment period (Week 12 and Week 20)
Title
Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S):Depression
Description
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).
Time Frame
Week 8 of each treatment period (Week 12 and Week 20)
Title
Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Mania
Description
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)
Time Frame
Week 8 of each treatment period (Week 12 and Week 20)
Title
Clinical Global Impression-Bipolar-Change (CGI-BP-C):Overall Bipolar Illness
Description
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.
Time Frame
Week 8 of each treatment period (Week 12 and Week 20)
Title
Clinical Global Impression-Bipolar-Change (CGI-BP-C):Depression
Description
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.
Time Frame
Week 8 of each treatment period (Week 12 and Week 20)
Title
Clinical Global Impression-Bipolar-Change (CGI-BP-C):Mania
Description
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.
Time Frame
Week 8 of each treatment period (Week 12 and Week 20)
Title
Number of Participants With Adverse Events
Description
An adverse event (AE) is defined as any undesirable or unintended sign (including abnonmal 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, required or prolonged hospitalization or was considered medically important.
Time Frame
Up to 22 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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 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 the start of the pre-treatment observation period.
Unable to suspend antipsychotics or antidepressants after the start of the pre-treatment observation period.
Treatment with more than one of the following three drugs, mood stabilizers (lithium carbonate and/or sodium valproate) and lamotrigine, if these drugs, except one of either drugs, cannot be suspended after the start of the pre-treatment observation period.
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 the start of the pre-treatment observation period.
Unable to suspend CYP3A4 inhibitors or inducers, or monoamine oxidase (MAO) inhibitors from 7 days before the start of the pre-treatment observation period.
Electroconvulsive therapy within the last 83 days before the start of the pre-treatment observation period.
A possible need of psychotherapy during the study period (unless the therapy has been commenced at least 83 days before the start of the pre-treatment observation period).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Fukushima
Country
Japan
City
Kanagawa
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Osaka
Country
Japan
City
Tokushima
Country
Japan
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Citations:
PubMed Identifier
32792252
Citation
Fukushi R, Nomura Y, Katashima M, Komatsu K, Sato Y, Takada A. Approach to Evaluating QT Prolongation of Quetiapine Fumarate in Late Stage of Clinical Development Using Concentration-QTc Modeling and Simulation in Japanese Patients With Bipolar Disorder. Clin Ther. 2020 Aug;42(8):1483-1493.e1. doi: 10.1016/j.clinthera.2020.06.002. Epub 2020 Aug 11.
Results Reference
derived
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=205
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
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