Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height) - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00303602

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder Bipolar Disorder	Drug: Sublingual orally disintegrating olanzapine (SODO) Drug: Oral olanzapine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	BMI Evaluation: Placebo and Active Comparator Trial of Olanzapine Zydis Pills Used Sublingually (PLATYPUS)

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Diabetes Medicines Mental Disorders Psychotic Disorders Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Time Course of Change From Baseline in Body Mass Index (BMI) [ Time Frame: Visit 2 (Baseline) to Visit 7 (16 Weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers [ Time Frame: Visit 2 (Baseline) and Visit 7 (16 Weeks) ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to 16 Week Endpoint in Weight [ Time Frame: Visit 2 (Baseline) and Visit 7 (16 Weeks) ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to 16 Week Endpoint in Waist Circumference [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period [ Time Frame: Visit 2 (Baseline) to Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
Number of Participants Discontinuing the Trial by Visit (Week) [ Time Frame: Visit 2 (Baseline) to Visit 7 (Week 16) ] [ Designated as safety issue: No ]
Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: No ]
Mean Change From Baseline to 16 Week Endpoint in Blood Pressure [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
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) [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated) [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: No ]
Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: No ]
Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: No ]

Enrollment:	149
Study Start Date:	March 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Sublingual orally disintegrating olanzapine (SODO)	Drug: Sublingual orally disintegrating olanzapine (SODO) 5 to 20mg dose, supplied in 5mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks. Other Names: LY170053 Zydis
Active Comparator: B Oral olanzapine	Drug: Oral olanzapine 5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks. Other Names: LY170053 Zyprexa

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303602

Locations

United States, California
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, 92025
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, 92845
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, 91950
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, 92868
United States, Georgia
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, 30308
United States, Nevada
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, 89102
United States, New York
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, 10312
Canada, British Columbia
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Penticton, British Columbia, Canada, V2A 4M4
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3N4
Canada, Nova Scotia
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Dartmouth, Nova Scotia, Canada, B2Y 3Z9
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, B3H 2E2
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, B1S 2E8
Canada, Ontario
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, N7L 1B7
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, K7L 4X3
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, P3C 1T4
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, N9C 3Z4
Canada, Quebec
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, J1G 1W4
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, Mexico, 01030
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, 3816 CP
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, Netherlands, 3015 GD
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, Puerto Rico, 00918

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00303602 History of Changes
Other Study ID Numbers:	10268, F1D-CA-S063
Study First Received:	March 15, 2006
Results First Received:	December 19, 2008
Last Updated:	June 5, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bipolar Disorder
Psychotic Disorders
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012