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OpenTrials
Completed

NCT Number: NCT00303602

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sublingual orally disintegrating olanzapine (SODO)

Drug

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

Oral olanzapine

Drug

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

Other names: LY170053, Zyprexa

Primary outcomes

  1. Time Course of Change From Baseline in Body Mass Index (BMI)

    Time frame: Visit 2 (Baseline) to Visit 7 (16 Weeks)

    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.

Secondary outcomes

  1. Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)

    Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)

    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)

  2. 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)

    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.

  3. Mean Change From Baseline to 16 Week Endpoint in Weight

    Time frame: Visit 2 (Baseline) and Visit 7 (16 Weeks)

    Weight of undressed patient (undergarments allowed), measured preferably at the same time each day.

  4. Mean Change From Baseline to 16 Week Endpoint in Waist Circumference

    Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)

    Waist circumference is measured on a bare abodomen just above the hip bone.

  5. 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)

    Percentage loss of body weight = 100*(postbaseline weight - baseline weight)/baseline weight

  6. Number of Participants Discontinuing the Trial by Visit (Week)

    Time frame: Visit 2 (Baseline) to Visit 7 (Week 16)

    The number of participants who discontinued by visit (non-cumulative).

  7. 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)

    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.

  8. Mean Change From Baseline to 16 Week Endpoint in Blood Pressure

    Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)

    Sitting blood pressure, taken from the same arm.

  9. 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)

    Patients should be fasting a minimum of eight hours prior to lipoprotein measurements.

  10. Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose

    Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)

    Patients should be fasting a minimum of eight hours prior to plasma glucose measurement.

  11. Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin

    Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)

    Patients should be fasting a minimum of eight hours prior to serum insulin measurement.

  12. Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin

    Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)

  13. 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)

    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.

  14. 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)

    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

  15. 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)

    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).

  16. 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)

    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.

  17. 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)

    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).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 17, 2006
Registry last updated
Jun 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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