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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
A tablet containing 50 mg or 150 mg of quetiapine taken orally.
Unnamed facility
Fukushima, Japan
Unnamed facility
Kanagawa, Japan
Unnamed facility
Kumamoto, Japan
Unnamed facility
Kyoto, Japan
Unnamed facility
Osaka, Japan
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.
Time frame: Week 8 of each treatment period (Week 12 and Week 20)
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.
Time frame: Week 8 of each treatment period (Week 12 and Week 20)
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).
Time frame: Week 8 of each treatment period (Week 12 and Week 20)
Clinical Global Impression-Bipolar-Severity of Illness (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).
Time frame: Week 8 of each treatment period (Week 12 and Week 20)
Clinical Global Impression-Bipolar-Severity of Illness (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)
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Unnamed facility
Tokushima, Japan
Unnamed facility
Tokyo, Japan
Time frame: Week 8 of each treatment period (Week 12 and Week 20)
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.
Time frame: Week 8 of each treatment period (Week 12 and Week 20)
Clinical Global Impression-Bipolar-Change (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.
Time frame: Week 8 of each treatment period (Week 12 and Week 20)
Clinical Global Impression-Bipolar-Change (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.
Time frame: Week 8 of each treatment period (Week 12 and Week 20)
Number of Participants With Adverse Events
An adverse event (AE) is defined as any undesirable or unintended sign (including abnonmal 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, required or prolonged hospitalization or was considered medically important.
Time frame: Up to 22 weeks