Phase 3
Completed N=20
Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
Source: ClinicalTrials.gov NCT02362412 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — 7.4; 7.9 UNITS ON A SCALE
◆ Published Evidence
Emerging
2citations · ~0 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
7.4; 7.9 | — |
| SECONDARY Hamilton Depression Scale (HAM-D17) |
5.5; 5.4 | — |
| SECONDARY Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness |
2.1; 2.0 | — |
| SECONDARY Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S):Depression |
2.1; 2.0 | — |
| SECONDARY Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Mania |
1.0; 1.0 | — |
| SECONDARY Clinical Global Impression-Bipolar-Change (CGI-BP-C):Overall Bipolar Illness |
2.0; 2.0 | — |
| SECONDARY Clinical Global Impression-Bipolar-Change (CGI-BP-C):Depression |
2.0; 2.0 | — |
| SECONDARY Clinical Global Impression-Bipolar-Change (CGI-BP-C):Mania |
4.0; 4.0 | — |
| SECONDARY Number of Participants With Adverse Events |
1; 2; 5; 2; 0; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02362412) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.