Phase 4
Completed N=149
Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)
Source: ClinicalTrials.gov NCT00303602 ↗Enrolled (actual)
149
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Time Course of Change From Baseline in Body Mass Index (BMI) — 0.09; 0.16; 0.25; 0.27 kilograms/square meters — p=0.428
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Course of Change From Baseline in Body Mass Index (BMI) |
0.09; 0.16; 0.25; 0.27; 0.34; 0.32 | 0.428 |
| SECONDARY Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) |
0.52; 0.67 | 0.442 |
| SECONDARY Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers |
0.56; 0.79 | 0.328 |
| SECONDARY Mean Change From Baseline to 16 Week Endpoint in Weight |
1.42; 2.08 | 0.385 |
| SECONDARY Mean Change From Baseline to 16 Week Endpoint in Waist Circumference |
1.13; 0.77 | 0.914 |
| SECONDARY Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period |
0; 0; 0; 1; 2; 2 | 0.325 |
| SECONDARY Number of Participants Discontinuing the Trial by Visit (Week) |
3; 1; 3; 1; 5; 6 | — |
| SECONDARY Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale |
-8.21; -5.02 | 0.344 |
| SECONDARY Mean Change From Baseline to 16 Week Endpoint in Blood Pressure |
0.1; -0.1; 0.3; 0.8 | 0.708 |
| SECONDARY 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) |
0.1; 0.2; -0.0; -0.0; 0.1; 0.2 | 0.187 |
| SECONDARY Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose |
0.2; 0.1 | 0.227 |
| SECONDARY Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin |
2.4; -0.1 | 0.020 sig |
| SECONDARY Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin |
0.0; 0.0 | 0.834 |
| SECONDARY Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated) |
-18.5; -9.8 | 0.022 sig |
| SECONDARY 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 |
18; 16; 18; 10 | 0.515 |
| SECONDARY Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale |
-0.26; -0.09 | 0.118 |
| SECONDARY Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale |
4.79; 1.60 | 0.161 |
| SECONDARY Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale |
4.61; 2.72 | 0.229 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00303602). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.