Schizophrenia Clinical Trial
Official title:
BMI Evaluation: Placebo and Active Comparator Trial of Olanzapine Zydis Pills Used Sublingually (PLATYPUS)
| Verified date | June 2009 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 149 |
| Est. completion date | December 2007 |
| Est. primary completion date | December 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria (Patients must): - Be at least 18 years old - Have gained weight while taking olanzapine - Be able to visit the doctor's office seven times over 4 months (17 weeks) Exclusion Criteria (Patients must NOT): - Have started a weight loss program within the last 8 weeks - Have an illness that might affect patient's weight during the study - Have an allergy to phenylalanine, mannitol or saccharine - Be taking any medication (except for olanzapine) that might affect patient's weight |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| 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 | 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 |
| 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 |
| 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. | 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. | Sherbrooke | Quebec |
| 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. | Sudbury | Ontario |
| 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 |
| 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 |
| 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 |
| 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. | Mexico City | |
| 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. | Amersfoort | |
| 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 | |
| Puerto Rico | 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 | |
| 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. | 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. | 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. | 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. | Staten Island | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Canada, Mexico, Netherlands, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time Course of Change From Baseline in Body Mass Index (BMI) | Visit 2 (Baseline) to Visit 7 (16 Weeks) | Yes | |
| Secondary | Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) | Visit 2 (Baseline) and Visit 7 (Week 16) | Yes | |
| Secondary | 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) | Yes | |
| Secondary | Mean Change From Baseline to 16 Week Endpoint in Weight | Visit 2 (Baseline) and Visit 7 (16 Weeks) | Yes | |
| Secondary | Mean Change From Baseline to 16 Week Endpoint in Waist Circumference | Visit 2 (Baseline) and Visit 7 (Week 16) | Yes | |
| Secondary | Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period | Visit 2 (Baseline) to Visit 7 (Week 16) | Yes | |
| Secondary | Number of Participants Discontinuing the Trial by Visit (Week) | Visit 2 (Baseline) to Visit 7 (Week 16) | No | |
| Secondary | Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale | Visit 2 (Baseline) and Visit 7 (Week 16) | No | |
| Secondary | Mean Change From Baseline to 16 Week Endpoint in Blood Pressure | Visit 2 (Baseline) and Visit 7 (Week 16) | Yes | |
| 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) | Visit 2 (Baseline) and Visit 7 (Week 16) | Yes | |
| Secondary | Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose | Visit 2 (Baseline) and Visit 7 (Week 16) | Yes | |
| Secondary | Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin | Visit 2 (Baseline) and Visit 7 (Week 16) | Yes | |
| Secondary | Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin | Visit 2 (Baseline) and Visit 7 (Week 16) | Yes | |
| Secondary | 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) | Yes | |
| 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 | Visit 2 (Baseline) and Visit 7 (Week 16) | Yes | |
| Secondary | 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) | No | |
| Secondary | 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) | No | |
| Secondary | Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale | Visit 2 (Baseline) and Visit 7 (Week 16) | No |
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