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| ID | Type | Description | Link |
|---|---|---|---|
| F1D-CA-S063 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Sublingual orally disintegrating olanzapine (SODO) |
|
| B | Active Comparator | Oral olanzapine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual orally disintegrating olanzapine (SODO) | Drug | 5 to 20mg dose, supplied in 5mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 2 (Baseline) to Visit 7 (16 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 |
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Inclusion Criteria (Patients must):
Exclusion Criteria (Patients must NOT):
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | 92025 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20840778 | Derived | Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72. doi: 10.1186/1471-244X-10-72. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SODO | Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks |
| FG001 | SOT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Oral olanzapine | Drug | 5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 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. |
| 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. | 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. | 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 | 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). | 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. | 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. | 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. | 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. | 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. | Visit 2 (Baseline) and Visit 7 (Week 16) |
| 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) | 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. | 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 | 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). | 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. | 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). | Visit 2 (Baseline) and Visit 7 (Week 16) |
| 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 | 92845 | 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 | 91950 | 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 | 92868 | 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 | 30308 | 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 | 89102 | 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 | 10312 | 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 | V2A 4M4 | 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 | R3E 3N4 | 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 | B2Y 3Z9 | 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. | Halifax | Nova Scotia | B3H 2E2 | 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. | Sydney | Nova Scotia | B1S 2E8 | 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. | Chatham | Ontario | N7L 1B7 | 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. | Greater Sudbury | Ontario | P3C 1T4 | 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. | Kingston | Ontario | K7L 4X3 | 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. | Windsor | Ontario | N9C 3Z4 | 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. | Sherbrooke | Quebec | J1G 1W4 | 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. | Mexico City | 01030 | Mexico |
| 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. | Amersfoort | 3816 CP | Netherlands |
| 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. | Rotterdam | 3015 GD | Netherlands |
| 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 | 00918 | Puerto Rico |
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SODO | Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks |
| BG001 | SOT | Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Presence of Metabolic Syndrome | Number | participants |
| ||||||||||||||||
| Psychiatric Illness | Number | participants |
| ||||||||||||||||
| Race/Ethnicity | Number | participants |
| ||||||||||||||||
| Blood Pressure | Mean | Standard Deviation | mm Hg |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kilograms/meters-squared |
| |||||||||||||||
| Clinical Global Impression-Severity 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Fasting Glucose | Mean | Standard Deviation | millimole/Liter |
| |||||||||||||||
| Fasting Insulin | Mean | Standard Deviation | micro International Unit/milliliter |
| |||||||||||||||
| Fasting Lipoproteins | Mean | Standard Deviation | millimole/Liter |
| |||||||||||||||
| Global Assessment of Functioning 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). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Glycosylated Hemoglobin | Mean | Standard Deviation | percent |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
| |||||||||||||||
| Subjective Appetite (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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Subjective Well-Being Under Neuroleptic Treatment - Short Form | 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 4 to 24. Total score ranges from 20 to 120. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Waist Circumference | Mean | Standard Deviation | centimeters |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention to treat | Posted | Least Squares Mean | Standard Error | kilograms/square meters | Visit 2 (Baseline) to Visit 7 (16 Weeks) |
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| Secondary | 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) | Intention to treat with last observation carried forward | Posted | Mean | Standard Deviation | kilograms/square meters | Visit 2 (Baseline) and Visit 7 (Week 16) |
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| Secondary | 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. | Per protocol | Posted | Mean | Standard Deviation | kilograms/square meters | Visit 2 (Baseline) and Visit 7 (16 Weeks) |
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| Secondary | Mean Change From Baseline to 16 Week Endpoint in Weight | Weight of undressed patient (undergarments allowed), measured preferably at the same time each day. | Intention to treat | Posted | Least Squares Mean | Standard Error | kilograms | Visit 2 (Baseline) and Visit 7 (16 Weeks) |
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| Secondary | Mean Change From Baseline to 16 Week Endpoint in Waist Circumference | Waist circumference is measured on a bare abodomen just above the hip bone. | Intention to treat with last observation carried forward | Posted | Mean | Standard Deviation | centimeters | Visit 2 (Baseline) and Visit 7 (Week 16) |
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| Secondary | 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 | Intention to treat | Posted | Number | participants | Visit 2 (Baseline) to Visit 7 (Week 16) |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Discontinuing the Trial by Visit (Week) | The number of participants who discontinued by visit (non-cumulative). | Intention to treat | Posted | Number | participants | Visit 2 (Baseline) to Visit 7 (Week 16) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat | Posted | Least Squares Mean | Standard Error | units on a scale | Visit 2 (Baseline) and Visit 7 (Week 16) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to 16 Week Endpoint in Blood Pressure | Sitting blood pressure, taken from the same arm. | Safety population with last observation carried forward | Posted | Mean | Standard Deviation | mm Hg | Visit 2 (Baseline) and Visit 7 (Week 16) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety population with last observation carried forward | Posted | Mean | Standard Deviation | millimole/Liter | Visit 2 (Baseline) and Visit 7 (Week 16) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety population with last observation carried forward | Posted | Mean | Standard Deviation | millimole/Liter | Visit 2 (Baseline) and Visit 7 (Week 16) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety population with last observation carried forward | Posted | Mean | Standard Deviation | microIU/milliliter | Visit 2 (Baseline) and Visit 7 (Week 16) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin | Safety population with last observation carried forward | Posted | Mean | Standard Deviation | percent | Visit 2 (Baseline) and Visit 7 (Week 16) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety population with last observation carried forward. | Posted | Mean | Standard Deviation | percent sensitivity | Visit 2 (Baseline) and Visit 7 (Week 16) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Intention to treat | Posted | Number | participants | Visit 2 (Baseline) and Visit 7 (Week 16) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Intention to treat | Posted | Least Squares Mean | Standard Error | units on a scale | Visit 2 (Baseline) and Visit 7 (Week 16) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat | Posted | Least Squares Mean | Standard Error | units on a scale | Visit 2 (Baseline) and Visit 7 (Week 16) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Intention to treat | Posted | Least Squares Mean | Standard Error | units on a scale | Visit 2 (Baseline) and Visit 7 (Week 16) |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SODO | Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks | 2 | 32 | ||||
| EG001 | SOT | Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks | 0 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Tongue spasm | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Tooth fracture | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Tenderness | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 8.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 8.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Tongue paralysis | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Psychomotor agitation | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Mexico |
|
| Canada |
|
| Netherlands |
|
| Yes |
|
| Unknown |
|
| Schizophreniform |
|
| Schizoaffective disorder |
|
| Other related psychiatric disorder |
|
| Bipolar disorder |
|
| Caucasian |
|
| East/Southeast Asian |
|
| First Nations |
|
| Hispanic |
|
| Other |
|
| Diastolic Blood Pressure |
|
| High-Density Lipoprotein Cholesterol |
|
| Low-Density Lipoprotein Cholesterol |
|
| Triglycerides |
|
| Social Integration Subscale |
|
| Physical Functioning Subscale |
|
| Mental Functioning Subscale |
|
| Self-Control Subscale |
|
| Emotional Regulation Subscale |
|
| Week 8 (N=75, N=58) |
|
| Week 12 (N=70, N=54) |
|
| Week 16 (N=67, N=51) |
|
| 0.859 |
P-value for Week 4 Change from Baseline. There was no adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.885 | P-value for Week 8 Change from Baseline. There was no adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Mixed Models Analysis | 0.784 | P-value for Week 12 Change from Baseline. There was no adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Mixed Models Analysis | 0.465 | P-value for Week 16 Change from Baseline. There was no adjustment for multiple comparisons | 95 | No | Superiority or Other |
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