Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• 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.
• Drug: Oral olanzapine
  • 5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Sublingual orally disintegrating olanzapine (SODO)
• Active Comparator: B
  • Oral olanzapine

Primary Measures

• Time Course of Change From Baseline in Body Mass Index (BMI)
  • Time Frame: Visit 2 (Baseline) to Visit 7 (16 Weeks)
    Safety Issue?: Yes

Secondary Measures

• Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)
  • Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16)
    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)
    Safety Issue?: Yes
• Mean Change From Baseline to 16 Week Endpoint in Weight
  • Time Frame: Visit 2 (Baseline) and Visit 7 (16 Weeks)
    Safety Issue?: Yes
• Mean Change From Baseline to 16 Week Endpoint in Waist Circumference
  • Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16)
    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)
    Safety Issue?: Yes
• Number of Participants Discontinuing the Trial by Visit (Week)
  • Time Frame: Visit 2 (Baseline) to Visit 7 (Week 16)
    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)
    Safety Issue?: No
• Mean Change From Baseline to 16 Week Endpoint in Blood Pressure
  • Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16)
    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)
    Safety Issue?: Yes
• Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose
  • Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16)
    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)
    Safety Issue?: Yes
• Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin
  • Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16)
    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)
    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)
    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)
    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)
    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)
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00303602

Study ID Number: 10268

ClinicalTrials.gov Identifier: NCT00303602

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry