Sublingual orally disintegrating olanzapine (SODO)
Drug5 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
NCT Number: NCT00303602
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Patients must):
Exclusion criteria
(Patients must NOT):
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
5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.
Other names: LY170053, Zyprexa
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.
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)
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.
Time frame: Visit 2 (Baseline) and Visit 7 (16 Weeks)
Weight of undressed patient (undergarments allowed), measured preferably at the same time each day.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Waist circumference is measured on a bare abodomen just above the hip bone.
Time frame: Visit 2 (Baseline) to Visit 7 (Week 16)
Percentage loss of body weight = 100*(postbaseline weight - baseline weight)/baseline weight
Time frame: Visit 2 (Baseline) to Visit 7 (Week 16)
The number of participants who discontinued by visit (non-cumulative).
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.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Sitting blood pressure, taken from the same arm.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Patients should be fasting a minimum of eight hours prior to lipoprotein measurements.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Patients should be fasting a minimum of eight hours prior to plasma glucose measurement.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
Patients should be fasting a minimum of eight hours prior to serum insulin measurement.
Time frame: Visit 2 (Baseline) and Visit 7 (Week 16)
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.
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
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).
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.
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).
Eli Lilly and Company
Industry
BMI Evaluation: Placebo and Active Comparator Trial of Olanzapine Zydis Pills Used Sublingually (PLATYPUS)
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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