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

Sponsored by:	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

MedlinePlus related topics: Bipolar Disorder Psychotic Disorders Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Assess any difference in Body Mass Index (BMI) between treatment as measured by mean change from baseline to endpoint using mixed model repeated measurement (MMRM) methodology. [ Time Frame: 16 weeks (Visits 2 to 7) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess the mean change in BMI from baseline to endpoint using last observation carry forward (LOCF) methodology between treatment groups. [ Time Frame: 16 weeks (Visits 2 to 7) ] [ Designated as safety issue: Yes ]
Assess the mean change in BMI from baseline to endpoint using treatment completer methodology between treatment groups. [ Time Frame: 16 weeks (Visits 2 to 7) ] [ Designated as safety issue: Yes ]
Assess the mean change in weight from baseline to endpoint between treatment groups. [ Time Frame: 16 weeks (Visits 2 to 7) ] [ Designated as safety issue: Yes ]
Assess the mean change in waist circumference from baseline to endpoint between treatment groups. [ Time Frame: 16 weeks (Visits 2, 5 and 7) ] [ Designated as safety issue: Yes ]
Assess the proportion of patients in each group achieving at least 5% loss of body weight in any post-baseline period. [ Time Frame: 16 weeks (Visits 2 to 7) ] [ Designated as safety issue: Yes ]
To assess whether SODO is associated with better treatment adherence than oral olanzapine in the study population as measured by comparing the difference in numbers of patients dropping out in each treatment arm post-baseline. [ Time Frame: 16 weeks (Visits 2 to 7) ] [ Designated as safety issue: No ]
Assess differences in subjective appetite from baseline to endpoint in patients taking SODO compared with oral olanzapine, using a visual analog scale. [ Time Frame: 16 weeks (Visits 2 to 7) ] [ Designated as safety issue: No ]
To assess mean changes from baseline to endpoint in blood pressure. [ Time Frame: 17 weeks (Visits 1 and 7) ] [ Designated as safety issue: Yes ]
To assess the mean changes from baseline to endpoint in fasting lipoproteins (total cholesterol, high-density lipoprotein cholesterol [HDL-cholesterol], low-density lipoprotein cholesterol [LDL-cholesterol] [calculated], and triglycerides). [ Time Frame: 17 weeks (Visits 1, 5, 6 and 7) ] [ Designated as safety issue: Yes ]
To assess the changes from baseline to endpoint in fasting plasma glucose [ Time Frame: 17 weeks (Visit 1, 5, 6 and 7) ] [ Designated as safety issue: Yes ]
To assess the mean changes from baseline to endpoint in fasting serum insulin. [ Time Frame: 17 weeks (Visits 1, 5 and 7) ] [ Designated as safety issue: Yes ]
To assess the mean changes from baseline to endpoint in glycosylated hemoglobin. [ Time Frame: 17 weeks (Visits 1, 5 and 7) ] [ Designated as safety issue: Yes ]
To assess mean changes from baseline to endpoint in insulin sensitivity as measured by HOMA-S (calculated). [ Time Frame: 17 weeks (Visits 1, 5 and 7) ] [ Designated as safety issue: Yes ]
To assess the proportions of patients in each group meeting a definition for the presence of metabolic syndrome as defined by ATP III criteria at baseline and endpoint. [ Time Frame: 17 weeks (Visits 1 and 7) ] [ Designated as safety issue: Yes ]
To assess the efficacy of SODO as compared with oral olanzapine during the double-blind treatment phase in the study population as measured by mean change from baseline to endpoint in the Clinical Global Impression-Severity (CGI-S) scale. [ Time Frame: 16 weeks (Visits 2 to 7) ] [ Designated as safety issue: No ]
To assess the efficacy of SODO compared with oral olanzapine during the double-blind treatment period in the study population as measured by mean change from baseline to endpoint in the Subjective Well-being Under Neuroleptics (SWN) scale. [ Time Frame: 16 weeks (Visits 2 to 7) ] [ Designated as safety issue: No ]
To assess the efficacy of SODO compared with oral olanzapine during the double-blind treatment period in the study population as measured by the mean change from baseline to endpoint in the Global Assessment of Functioning (GAF) scale. [ Time Frame: 16 weeks (Visits 2 to 7) ] [ Designated as safety issue: No ]

Enrollment:	151
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
A: Experimental 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.
B: Active Comparator Oral olanzapine	Drug: Oral olanzapine 5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.

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.
Orange, California, United States, 92868
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
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
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, V2A 4M4
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3N4
Canada, Nova Scotia
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, 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

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

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10268, F1D-CA-S063
Study First Received:	March 15, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00303602
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Body Weight
Affective Disorders, Psychotic
Bipolar disorder
Mental Disorders
Bipolar Disorder

Olanzapine
Mood Disorders
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 11, 2009