Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
placebo, capsules, by mouth every evening, daily, for 6 weeks.
dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 52 days (Study Period I and Study Period II).
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hialeah, Florida, United States
Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.
The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
Time frame: Baseline to endpoint (6 weeks)
Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint.
The 21-item HAMD measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.
Time frame: Baseline to endpoint (6 weeks)
Number of Participants Meeting the Criteria for Mixed Onset of Action
The original outcome measure was Time to Mixed Onset of Action (at least a 25% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.
Time frame: Baseline to endpoint (6 weeks)
Number of Participants Meeting the Criteria for Mixed Response
The original outcome measure was Time to Mixed Response(at least a 50% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.
Time frame: baseline to endpoint (6 weeks)
Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint
CGI-BP Severity is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline to endpoint (6 weeks)
Number of Patients Hospitalized Due to Relapse of Mania or Depression.
Number of participants hospitalized as a result of relapse of mania or depression.
Time frame: Baseline to endpoint (6 weeks)
Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline
Change from Baseline to endpoint in cholesterol: value of cholesterol measure at endpoint minus the value at baseline.
Time frame: Baseline to endpoint (6 weeks)
Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline
Change from baseline to endpoint in triglycerides: Value of triglyceride measure at endpoint minus value at baseline.
Time frame: Baseline to endpoint (6 weeks)
Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline
Change from baseline to endpoint in fasting blood glucose: Value of fasting blood glucose measure at endpoint minus value at baseline.
Time frame: Baseline to endpoint (6 weeks)
Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline
Change from baseline to endpoint in bilirubin total: Value of bilirubin total measure at endpoint minus value at baseline.
Time frame: Baseline to endpoint (6 weeks)
Clinically Significant Vital Signs - Body Mass Index Change From Baseline
Change from baseline to endpoint in body mass index (an estimate of body fat derived by dividing body weight by height squared): Value of body mass index measure at endpoint minus value at baseline.
Time frame: Baseline to endpoint (6 weeks)
Clinically Significant Vital Signs - Weight Change From Baseline
Change from baseline to endpoint: Value of weight measure at endpoint minus value at baseline.
Time frame: Baseline to endpoint (6 weeks)
Clinically Significant Vital Signs - Percentage of Participants With Baseline-to-Endpoint Weight Increase of at Least Seven Percent (7%)
Percentages of participants in each group who experienced an increase in weight of at least 7% from baseline to endpoint.
Time frame: Baseline to endpoint (6 weeks)