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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01737268
Other study ID # 6949-CL-0022
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 29, 2012
Est. completion date June 29, 2016

Study information

Verified date January 2019
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 29, 2016
Est. primary completion date June 29, 2016
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
FK949E
Oral tablet

Locations

Country Name City State
Japan Site JP00024 Chiba
Japan Site JP00023 Fukuoka
Japan Site JP00025 Fukuoka
Japan Site JP00015 Fukushima
Japan Site JP00029 Fukushima
Japan Site JP00001 Hokkaido
Japan Site JP00002 Hokkaido
Japan Site JP00003 Hokkaido
Japan Site JP00004 Hokkaido
Japan Site JP00005 Hokkaido
Japan Site JP00006 Hokkaido
Japan Site JP00007 Hokkaido
Japan Site JP00008 Hokkaido
Japan Site JP00009 Hokkaido
Japan Site JP00010 Hokkaido
Japan Site JP00011 Hokkaido
Japan Site JP00012 Hokkaido
Japan Site JP00013 Hokkaido
Japan Site JP00028 Hyogo
Japan Site JP00031 Ibaraki
Japan Site JP00017 Kanagawa
Japan Site JP00032 Kanagawa
Japan Site JP00019 Kumamoto
Japan Site JP00018 Kyoto
Japan Site JP00014 Osaka
Japan Site JP00016 Tokyo
Japan Site JP00020 Tokyo
Japan Site JP00021 Tokyo
Japan Site JP00022 Tokyo
Japan Site JP00026 Tokyo
Japan Site JP00027 Tokyo
Japan Site JP00030 Tottori

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17) The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 with lower scores indicating less depressive symptoms. Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill). Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill). Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill). Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary CGI-BP-C: Depression The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary CGI-BP-C: Mania The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Week 52 (or the time of last assessment for participants who discontinued earlier)
Secondary Number of Participants With Adverse Events An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, re quire d or prolonged hospitalization or was considered medically important. From first dose of study drug up to week 52 (52 weeks)
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