At a glance
ClinicalIndex Comparison Record- ✓At least 18 years old
- ✓Have experienced weight gain while taking olanzapine
- ✓Able to attend 7 clinic visits over approximately 4 months (17 weeks)
- ✕Started a weight loss program within 8 weeks prior to enrollment
- ✕Has an illness that might affect weight during the study
- ✕Allergy to phenylalanine, mannitol, or saccharine
- ✕Taking weight-affecting medications other than olanzapine
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BMI Evaluation: Placebo and Active Comparator Trial of Olanzapine Zydis Pills Used Sublingually (PLATYPUS)
In Brief
A Phase 4 clinical trial evaluating Sublingual orally disintegrating olanzapine (SODO) and Oral olanzapine for Schizophrenia and 2 related conditions. Completed, enrolled 149 participants across 21 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
5 to 20mg dose, supplied in 5mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks.
5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.