This study is testing if under the tongue olanzapine for schizophrenia, related psychosis, schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that is swallowed, in patients who are already gaining weight on olanzapine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
149
5 to 20mg dose, supplied in 5mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks.
5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.
Time Course of Change From Baseline in Body Mass Index (BMI)
Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.
Time frame: Visit 2 (Baseline) to Visit 7 (16 Weeks)
Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)
Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of change from baseline to endpoint. Change = Endpoint (Week 16) minus Baseline (Week 0)
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers
Body mass index is an estimate of body fat based on body weight divided by height squared. Comparisons of change from baseline to endpoint between participants who completed their treatment. Change = Endpoint value minus Baseline value.
Time frame: Visit 2 (Baseline) and Visit 7 (16 Weeks)
Mean Change From Baseline to 16 Week Endpoint in Weight
Weight of undressed patient (undergarments allowed), measured preferably at the same time each day.
Time frame: Visit 2 (Baseline) and Visit 7 (16 Weeks)
Mean Change From Baseline to 16 Week Endpoint in Waist Circumference
Waist circumference is measured on a bare abodomen just above the hip bone.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period
Percentage loss of body weight = 100\*(postbaseline weight - baseline weight)/baseline weight
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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.
Escondido, California, United States
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.
Garden Grove, California, United States
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.
National City, California, United States
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.
Orange, California, United States
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.
Atlanta, Georgia, United States
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.
Las Vegas, Nevada, United States
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.
Staten Island, New York, United States
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.
Penticton, British Columbia, Canada
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.
Winnipeg, Manitoba, Canada
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.
Dartmouth, Nova Scotia, Canada
...and 11 more locations
Time frame: Visit 2 (Baseline) to Visit 7 (Week 16)
Number of Participants Discontinuing the Trial by Visit (Week)
The number of participants who discontinued by visit (non-cumulative).
Time frame: Visit 2 (Baseline) to Visit 7 (Week 16)
Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale
Participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - very poor appetite and 10 - very strong appetite). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Blood Pressure
Sitting blood pressure, taken from the same arm.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)
Patients should be fasting a minimum of eight hours prior to lipoprotein measurements.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose
Patients should be fasting a minimum of eight hours prior to plasma glucose measurement.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin
Patients should be fasting a minimum of eight hours prior to serum insulin measurement.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated)
HOMA-S is an estimate of insulin sensitivity. The HOMA model is a computer model of the glucose insulin feedback system in the fasted state. The model consists of a number of non-linear empirical equations describing the functions of organs and tissues involved in glucose regulation.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint
Patient meets definition of metabolic syndrome if they have \>=3 risk factors: Waist circumference (men\>102cm, women\>88cm); triglycerides \>=1.7mmol/L; HDL cholesterol (men\<1.04mmol/L, women\<1.30mmol/L); blood pressure \>135/\>=85 mmHg; Fasting glucose \>=6.1mmol/L
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale
Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 1 to 24. Total score ranges from 1 to 120.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale
Measures physician's judgment of a patient's overall level of functioning. Ratings are based on a scale of 1 to 100, with the following classification range: 1-10 (severely impaired) to 91-100 (superior functioning).
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)