Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes

Astellas

Status and phase: Completed; Phase 3

Conditions: Bipolar Depression

Treatments: Drug: FK949E

Study type: Interventional

Funder types: Industry

Identifiers

NCT02362412

6949-CL-0023

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

FK949E 50 MG / FK949E 150 MG

Experimental group

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).

Treatment:

Drug: FK949E

FK949E 150 MG / FK949E 50 MG

Experimental group

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).

Treatment:

Drug: FK949E