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Completed

NCT Number: NCT01737268

Long-term Study of FK949E in Elderly Bipolar Disorder Patients

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Elderly Mental Disorders Mood Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site JP00024, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FK949E

Drug

Oral tablet

Other names: quetiapine

Primary outcomes

  1. Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    Time frame: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)

    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.

Secondary outcomes

  1. Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)

    Time frame: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)

    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.

  2. Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness

    Time frame: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)

    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).

  3. Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression

    Time frame: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)

    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).

  4. Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania

    Time frame: Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier)

    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).

  5. Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness

    Time frame: Week 52 (or the time of last assessment for participants who discontinued earlier)

    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.

  6. CGI-BP-C: Depression

    Time frame: Week 52 (or the time of last assessment for participants who discontinued earlier)

    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.

  7. CGI-BP-C: Mania

    Time frame: Week 52 (or the time of last assessment for participants who discontinued earlier)

    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.

  8. Number of Participants With Adverse Events

    Time frame: From first dose of study drug up to week 52 (52 weeks)

    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.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Long-term Study of FK949E in Elderly Patients -Long-term Study in Elderly Bipolar Disorder Patients With Major Depressive Episodes-

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 29, 2012
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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