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

Milton S. Hershey Medical Center15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Insulin Resistance Diabetes Mellitus

Interventions

Olanzapine 10 mg po qhs for 3 daysDRUG

(1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets)

PlaceboDRUG

(1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Plasma Leptin

Leptin following placebo or olanzapine treatment

Time frame: 3 Days

Oral Glucose Tolerance

Time frame: 3 Days

Plasma Free Fatty Acid

Time frame: 3 Days

Secondary Outcomes

HDL Cholesterol

Time frame: 3 Days

Triglycerides

Time frame: 3 Days

LDL Cholesterol

Time frame: 3 Days

Total Cholesterol

Time frame: 3 Days

Body Weight

Time frame: 3 Days

BMI

Time frame: 3 Days

Heart Rate

Time frame: 3 Days

Systolic Blood Pressure

Data from ClinicalTrials.gov

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