Long-term Study of FK949E in Elderly Bipolar Disorder Patients
This study is currently recruiting participants.
Verified November 2012 by Astellas Pharma Inc
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01737268
First received: November 8, 2012
Last updated: November 27, 2012
Last verified: November 2012
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Purpose
FK949E will be administered to elderly bipolar disorder patients with major depressive episode for 52 weeks. Its safety, efficacy, and plasma concentration change will be evaluated in an open-label manner.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Elderly |
Drug: FK949E |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Long-term Study of FK949E in Elderly Patients -Long-term Study in Elderly Bipolar Disorder Patients With Major Depressive Episodes- |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: Change from Baseline to 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- HAM-D17 [ Time Frame: Change from Baseline to 52 weeks ] [ Designated as safety issue: No ]HAM-D (Hamilton Depression Scale)
- Clinical Global Impression-Bipolar-Severity (CGI-BP-S) [ Time Frame: Change from Baseline to 52 weeks ] [ Designated as safety issue: No ]
- Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and Labo-tests [ Time Frame: for 52 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Elderly patients |
Drug: FK949E
oral
Other Name: quetiapine
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of bipolar I or II disorder as specified in the 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 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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737268
Contacts
| Contact: Clinical Development Administration Dept. | clintrialtrials_info@jp.astellas.com |
Locations
| Japan | |
| Recruiting | |
| Hokkaido, Japan | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Medical Director | Astellas Pharma Inc |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01737268 History of Changes |
| Other Study ID Numbers: | 6949-CL-0022 |
| Study First Received: | November 8, 2012 |
| Last Updated: | November 27, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Astellas Pharma Inc:
|
FK949E Major depressive episode patients |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013