Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)
- Conditions
- SchizophreniaSchizoaffective DisorderBipolar Disorder
- Interventions
- Drug: Sublingual orally disintegrating olanzapine (SODO)
- Registration Number
- NCT00303602
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Sublingual orally disintegrating olanzapine (SODO) Sublingual orally disintegrating olanzapine (SODO) B Oral olanzapine Oral olanzapine
- Primary Outcome Measures
Name Time Method Time Course of Change From Baseline in Body Mass Index (BMI) Visit 2 (Baseline) to Visit 7 (16 Weeks) 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.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) Visit 2 (Baseline) and Visit 7 (Week 16) 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)
Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers Visit 2 (Baseline) and Visit 7 (16 Weeks) 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.
Mean Change From Baseline to 16 Week Endpoint in Weight Visit 2 (Baseline) and Visit 7 (16 Weeks) Weight of undressed patient (undergarments allowed), measured preferably at the same time each day.
Mean Change From Baseline to 16 Week Endpoint in Waist Circumference Visit 2 (Baseline) and Visit 7 (Week 16) Waist circumference is measured on a bare abodomen just above the hip bone.
Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period Visit 2 (Baseline) to Visit 7 (Week 16) Percentage loss of body weight = 100\*(postbaseline weight - baseline weight)/baseline weight
Number of Participants Discontinuing the Trial by Visit (Week) Visit 2 (Baseline) to Visit 7 (Week 16) The number of participants who discontinued by visit (non-cumulative).
Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale Visit 2 (Baseline) and Visit 7 (Week 16) 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.
Mean Change From Baseline to 16 Week Endpoint in Blood Pressure Visit 2 (Baseline) and Visit 7 (Week 16) Sitting blood pressure, taken from the same arm.
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) Visit 2 (Baseline) and Visit 7 (Week 16) Patients should be fasting a minimum of eight hours prior to lipoprotein measurements.
Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose Visit 2 (Baseline) and Visit 7 (Week 16) Patients should be fasting a minimum of eight hours prior to plasma glucose measurement.
Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin Visit 2 (Baseline) and Visit 7 (Week 16) Patients should be fasting a minimum of eight hours prior to serum insulin measurement.
Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin 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) Visit 2 (Baseline) and Visit 7 (Week 16) 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.
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 Visit 2 (Baseline) and Visit 7 (Week 16) 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
Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale Visit 2 (Baseline) and Visit 7 (Week 16) 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).
Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale Visit 2 (Baseline) and Visit 7 (Week 16) 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.
Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale Visit 2 (Baseline) and Visit 7 (Week 16) 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).
Trial Locations
- Locations (1)
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.
🇵🇷San Juan, Puerto Rico