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

BMI Evaluation: Placebo and Active Comparator Trial of Olanzapine Zydis Pills Used Sublingually (PLATYPUS)

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
• Intervention / Treatment: Drug: Sublingual orally disintegrating olanzapine (SODO); Drug: Oral olanzapine

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Penticton, British Columbia, Canada, V2A 4M4
      • 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.
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3N4
      • 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.
  • Nova Scotia
    • 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
      • 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.
  • Ontario
    • 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
      • 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.
  • Quebec
    • Sherbrooke, Quebec, Canada, J1G 1W4
      • 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
  • Mexico City, Mexico, 01030
    • 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.
• Netherlands
  • 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
    • 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.
• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • 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.
• United States
  • California
    • 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
      • 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.
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • 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.
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • 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.
  • New York
    • Staten Island, New York, United States, 10312
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Zyprexa; LY170053

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• 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.

Helpful Links

• Lilly Clinical Trial Registry

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: March 15, 2006
• First Submitted That Met QC Criteria: March 15, 2006
• First Posted (Estimate): March 17, 2006

Study Record Updates

• Last Update Posted (Estimate): June 10, 2009
• Last Update Submitted That Met QC Criteria: June 5, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Disease; Psychotic Disorders; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: 10268 (Other Identifier: CTEP); F1D-CA-S063