Title
A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers
A Double-blind, Placebo-controlled, Crossover Study Examining the Acute Effects of Olanzapine on Plasma Leptin, Glucose Tolerance and Free Fatty Acids in Healthy Volunteers
Phase
N/ALead Sponsor
Pennsylvania State UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Insulin Resistance Diabetes MellitusIntervention/Treatment
olanzapine ...Study Participants
15The 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.
(1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets)
(1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
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
| Event Type | Organ System | Event Term |
|---|
Leptin following placebo or olanzapine treatment
Oral Glucose Tolerance
Plasma Free Fatty Acid
HDL Cholesterol
Triglycerides
LDL Cholesterol
Total Cholesterol
Body Weight
BMI
Heart Rate
Systolic Blood Pressure
Diastolic Blood Pressure
