Clinical trial NCT02362412: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Depression
Keywords: major depressive episodes
FK949E
quetiapine
bipolar depression
bipolar disorder
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-02-12
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Week 8 of each treatment period (Week 12 and Week 20)
Secondary outcomes:
measure: Hamilton Depression Scale (HAM-D17)
timeFrame: Week 8 of each treatment period (Week 12 and Week 20)
measure: Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness
timeFrame: Week 8 of each treatment period (Week 12 and Week 20)
measure: Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S):Depression
timeFrame: Week 8 of each treatment period (Week 12 and Week 20)
measure: Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Mania
timeFrame: Week 8 of each treatment period (Week 12 and Week 20)
measure: Clinical Global Impression-Bipolar-Change (CGI-BP-C):Overall Bipolar Illness
timeFrame: Week 8 of each treatment period (Week 12 and Week 20)
measure: Clinical Global Impression-Bipolar-Change (CGI-BP-C):Depression
timeFrame: Week 8 of each treatment period (Week 12 and Week 20)
measure: Clinical Global Impression-Bipolar-Change (CGI-BP-C):Mania
timeFrame: Week 8 of each treatment period (Week 12 and Week 20)
measure: Number of Participants With Adverse Events
timeFrame: Up to 22 weeks
Other outcomes:
Locations:
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
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
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.