SchizophreniaPhase 4NCT00303602
Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)
A Phase 4 study testing Sublingual orally disintegrating olanzapine (SODO) and Oral olanzapine in people with Schizophrenia and Schizoaffective Disorder, run by Eli Lilly and Company at 21 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- Sublingual orally disintegrating olanzapine (SODO) and Oral olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 21 sitesin 5 countries
- Study dates
- Mar 2006to Dec 2007
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
Canada10 sites
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, 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.
Dartmouth, Nova Scotia, 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.
Greater Sudbury, Ontario, 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.
Halifax, Nova Scotia, 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.
Kingston, Ontario, 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.
Penticton, British Columbia, 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.
Sherbrooke, Quebec, 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.
Sydney, Nova Scotia, 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.
Windsor, Ontario, 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.
Winnipeg, Manitoba, R3E 3N4
United States7 sites
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, 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.
Escondido, California, 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, 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.
Las Vegas, Nevada, 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.
National City, California, 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, 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.
Staten Island, New York, 10312
Netherlands2 sites
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, 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, 3015 GD
Mexico1 site
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, 01030
Puerto Rico1 site
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, 00918
About this study
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.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Being tested
- Sublingual orally disintegrating olanzapine (SODO), Oral olanzapine
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual orally disintegrating olanzapine (SODO)Drug
Also called LY170053, Zydis
5 to 20mg dose, supplied in 5mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks.
Oral olanzapineDrug
Also called LY170053, Zyprexa
5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Sublingual orally disintegrating olanzapine (SODO) Receives: Drug: Sublingual orally disintegrating olanzapine (SODO) |
| B | Active comparator | Oral olanzapine Receives: Drug: Oral olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 2 (Baseline) to Visit 7 (16 Weeks)
Secondary outcomes (17)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Visit 2 (Baseline) and Visit 7 (Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303602
- Sponsor's protocol ID
- 10268
- Other IDs
- F1D-CA-S063
- Status last verified
- Jun 2009
- First submitted
- 15 Mar 2006
- Last updated
- 10 Jun 2009
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 20840778