Clinical trial NCT00303602: Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)
Official title: BMI Evaluation: Placebo and Active Comparator Trial of Olanzapine Zydis Pills Used Sublingually (PLATYPUS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-03-17
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time Course of Change From Baseline in Body Mass Index (BMI)
timeFrame: Visit 2 (Baseline) to Visit 7 (16 Weeks)
Secondary outcomes:
measure: Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)
timeFrame: Visit 2 (Baseline) and Visit 7 (Week 16)
measure: Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers
timeFrame: Visit 2 (Baseline) and Visit 7 (16 Weeks)
measure: Mean Change From Baseline to 16 Week Endpoint in Weight
timeFrame: Visit 2 (Baseline) and Visit 7 (16 Weeks)
measure: Mean Change From Baseline to 16 Week Endpoint in Waist Circumference
timeFrame: Visit 2 (Baseline) and Visit 7 (Week 16)
measure: Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period
timeFrame: Visit 2 (Baseline) to Visit 7 (Week 16)
measure: Number of Participants Discontinuing the Trial by Visit (Week)
timeFrame: Visit 2 (Baseline) to Visit 7 (Week 16)
measure: Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale
timeFrame: Visit 2 (Baseline) and Visit 7 (Week 16)
measure: Mean Change From Baseline to 16 Week Endpoint in Blood Pressure
timeFrame: Visit 2 (Baseline) and Visit 7 (Week 16)
measure: 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)
timeFrame: Visit 2 (Baseline) and Visit 7 (Week 16)
measure: Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose
timeFrame: Visit 2 (Baseline) and Visit 7 (Week 16)
measure: Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin
timeFrame: Visit 2 (Baseline) and Visit 7 (Week 16)
measure: Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin
timeFrame: Visit 2 (Baseline) and Visit 7 (Week 16)
measure: Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated)
timeFrame: Visit 2 (Baseline) and Visit 7 (Week 16)
measure: 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
timeFrame: Visit 2 (Baseline) and Visit 7 (Week 16)
measure: Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale
timeFrame: Visit 2 (Baseline) and Visit 7 (Week 16)
measure: Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale
timeFrame: Visit 2 (Baseline) and Visit 7 (Week 16)
measure: Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale
timeFrame: Visit 2 (Baseline) and Visit 7 (Week 16)
Other outcomes:
Locations:
city: Escondido
country: United States
facility: 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.
state: California
city: Garden Grove
country: United States
facility: 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.
state: California
city: National City
country: United States
facility: 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.
state: California
city: Orange
country: United States
facility: 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.
state: California
city: Atlanta
country: United States
facility: 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.
state: Georgia
city: Las Vegas
country: United States
facility: 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.
state: Nevada
city: Staten Island
country: United States
facility: 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.
state: New York
city: Penticton
country: Canada
facility: 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.
state: British Columbia
city: Winnipeg
country: Canada
facility: 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.
state: Manitoba
city: Dartmouth
country: Canada
facility: 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.
state: Nova Scotia
city: Halifax
country: Canada
facility: 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.
state: Nova Scotia
city: Sydney
country: Canada
facility: 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.
state: Nova Scotia
city: Chatham
country: Canada
facility: 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.
state: Ontario
city: Kingston
country: Canada
facility: 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.
state: Ontario
city: Sudbury
country: Canada
facility: 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.
state: Ontario
city: Windsor
country: Canada
facility: 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.
state: Ontario
city: Sherbrooke
country: Canada
facility: 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.
state: Quebec
city: Mexico City
country: Mexico
facility: 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.
city: Amersfoort
country: Netherlands
facility: 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.
city: Rotterdam
country: Netherlands
facility: 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.
city: San Juan
country: Puerto Rico
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.