Phase 3
N=20
Long-term Study of FK949E in Elderly Bipolar Disorder Patients
Bipolar Disorder · Elderly
Bottom Line
View on ClinicalTrials.gov: NCT01737268 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Oct 2017
Primary outcome: Primary: Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — -13.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FK949E (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Astellas Pharma Inc
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-13.1 | — |
| SECONDARY Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17) |
-10.5 | — |
| SECONDARY Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness |
-1.2 | — |
| SECONDARY Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression |
-1.3 | — |
| SECONDARY Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania |
— | — |
| SECONDARY Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness |
2.4 | — |
| SECONDARY CGI-BP-C: Depression |
2.4 | — |
| SECONDARY CGI-BP-C: Mania |
4.0 | — |
| SECONDARY Number of Participants With Adverse Events |
18; 18; 0; 2; 1; 8 | — |
Summary
FK949E was administered to elderly bipolar disorder patients with major depressive episode for 52 weeks. Its safety, efficacy, and plasma concentration change were evaluated in an open-label manner.
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
- Male subjects must agree to take appropriate contraceptive measures with condoms during the study period.
- Female subjects must be confirmed to have no childbearing potential during the study period
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 was 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 more than 12 months or 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 primary registration.
- Unable to suspend antipsychotics or antidepressants after primary registration
- Treatment with two or more of mood stabilizers (lithium carbonate and/or sodium valproate) and lamotrigine, if these drugs, except one of either drug, cannot be suspended after primary registration.
- 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 primary registration
- Electroconvulsive therapy within the last 83 days before primary registration.
- A possible need of psychotherapy during the study period (unless the therapy has been commenced at least 83 days before primary registration).
- 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 (NCT01737268). 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.