A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Insulin Resistance, Diabetes Mellitus

Intervention / Treatment
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* Drug: Olanzapine 10 mg po qhs for 3 days
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* (1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)<br>* Other names: Sugar pill;|
| Experimental: Olanzapine<br>Olanzapine 10mg po daily x 3 days | Drug: Olanzapine 10 mg po qhs for 3 days<br>* (1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets)<br>* Other names: Zyprexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Leptin | Leptin following placebo or olanzapine treatment | 3 Days | 
| Oral Glucose Tolerance | Oral Glucose Tolerance | 3 Days | 
| Plasma Free Fatty Acid | Plasma Free Fatty Acid | 3 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL Cholesterol | HDL Cholesterol | 3 Days | 
| Triglycerides | Triglycerides | 3 Days | 
| LDL Cholesterol | LDL Cholesterol | 3 Days | 
| Total Cholesterol | Total Cholesterol | 3 Days | 
| Body Weight | Body Weight | 3 Days | 
| BMI | BMI | 3 Days | 
| Heart Rate | Heart Rate | 3 Days | 
| Systolic Blood Pressure | Systolic Blood Pressure | 3 Days | 
| Diastolic Blood Pressure | Diastolic Blood Pressure | 3 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin Resistance, Diabetes mellitus, Antipsychotic