Overview

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

Status:
Completed
Trial end date:
2016-02-06
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astellas Pharma Inc
Treatments:
Quetiapine Fumarate
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.