N/A
Completed N=15
A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers
Source: ClinicalTrials.gov NCT00741026 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Plasma Leptin — 6.8; 8.4 ng/ml — p=0.0203
Summary
The purpose of this clinical research study is to examine the acute hormonal and metabolic effects of the drug olanzapine, as well as appetite effects, in healthy volunteers. The hypotheses to be tested are that: (1) Olanzapine rapidly attenuates plasma leptin and (2) rapidly alters glucose tolerance in healthy volunteers. These questions will be answered by having volunteers undergo two glucose tolerance tests in a crossover study design.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Leptin |
6.8; 8.4 | 0.0203 sig |
| PRIMARY Oral Glucose Tolerance |
2808; 3984 | 0.0105 sig |
| PRIMARY Plasma Free Fatty Acid |
0.38; 0.26 | 0.0166 sig |
| SECONDARY HDL Cholesterol |
54.2; 48.9 | 0.0184 sig |
| SECONDARY Triglycerides |
88.9; 108.2 | 0.0170 sig |
| SECONDARY LDL Cholesterol |
82.7; 81.7 | — |
| SECONDARY Total Cholesterol |
156.8; 152.6 | — |
| SECONDARY Body Weight |
68.2; 68.9 | — |
| SECONDARY BMI |
23.0; 23.0 | — |
| SECONDARY Heart Rate |
69.9; 67.6 | — |
| SECONDARY Systolic Blood Pressure |
113.3; 111.7 | — |
| SECONDARY Diastolic Blood Pressure |
68.3; 69.5 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy Volunteer
- Body Mass Index of 18.5-25 kilograms per square meter
- Must be able to swallow tablets
- Able to give informed consent
Exclusion Criteria
- Any DSM-IV TR Axis I psychiatric disorder (except nicotine dependence)
- Presence of any medical disorder that may confound the assessment of relevant biologic measures, including: significant organ system dysfunction, metabolic diseases, type 1 diabetes mellitus, type 2 diabetes mellitus, pregnancy, endocrine disease, coagulopathy, clinically significant anemia, or acute infection
- Subjects who have taken any antipsychotic medication within the last 6 months
- Personal or family history of seizures and/or cardiac arrhythmias
Data sourced from ClinicalTrials.gov (NCT00741026). 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.