Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
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
1 other identifier
interventional
22
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2015
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2015
CompletedFirst Posted
Study publicly available on registry
February 12, 2015
CompletedStudy Start
First participant enrolled
February 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2016
CompletedResults Posted
Study results publicly available
March 17, 2017
CompletedNovember 15, 2024
October 1, 2024
12 months
February 3, 2015
January 26, 2017
October 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Week 8 of each treatment period (Week 12 and Week 20)
Secondary Outcomes (8)
Hamilton Depression Scale (HAM-D17)
Week 8 of each treatment period (Week 12 and Week 20)
Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness
Week 8 of each treatment period (Week 12 and Week 20)
Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S):Depression
Week 8 of each treatment period (Week 12 and Week 20)
Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Mania
Week 8 of each treatment period (Week 12 and Week 20)
Clinical Global Impression-Bipolar-Change (CGI-BP-C):Overall Bipolar Illness
Week 8 of each treatment period (Week 12 and Week 20)
- +3 more secondary outcomes
Study Arms (2)
FK949E 50 MG / FK949E 150 MG
EXPERIMENTALParticipants 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).
FK949E 150 MG / FK949E 50 MG
EXPERIMENTALParticipants 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).
Interventions
A tablet containing 50 mg or 150 mg of quetiapine taken orally.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Fukushima, Japan
Unknown Facility
Kanagawa, Japan
Unknown Facility
Kumamoto, Japan
Unknown Facility
Kyoto, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Tokushima, Japan
Unknown Facility
Tokyo, Japan
Related Publications (1)
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.
PMID: 32792252DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice-President, Japan-Asia Clinical Development Administration
- Organization
- Astellas Pharma Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2015
First Posted
February 12, 2015
Study Start
February 18, 2015
Primary Completion
February 6, 2016
Study Completion
February 6, 2016
Last Updated
November 15, 2024
Results First Posted
March 17, 2017
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.