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

Not Applicable

Completed

• Conditions: Insulin Resistance; Diabetes Mellitus
• Interventions: Drug: Olanzapine 10 mg po qhs for 3 days; Drug: Placebo

• Registration Number: NCT00741026
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-22
• Study First Posted: 2008-08-25
• Primary Completion: 2010-12
• Study Completion: 2011-05
• Results First Submitted: 2012-11-29
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-11
• Last Update Submitted: 2014-07-11
• Results First Posted: 2014-07-14
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Olanzapine	Olanzapine 10 mg po qhs for 3 days	Olanzapine 10mg po daily x 3 days
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Plasma Free Fatty Acid	3 Days	Plasma Free Fatty Acid
Oral Glucose Tolerance	3 Days	Oral Glucose Tolerance
Plasma Leptin	3 Days	Leptin following placebo or olanzapine treatment

Secondary Outcome Measures

Name	Time	Method
LDL Cholesterol	3 Days	LDL Cholesterol
BMI	3 Days	BMI
Diastolic Blood Pressure	3 Days	Diastolic Blood Pressure
Triglycerides	3 Days	Triglycerides
HDL Cholesterol	3 Days	HDL Cholesterol
Systolic Blood Pressure	3 Days	Systolic Blood Pressure
Total Cholesterol	3 Days	Total Cholesterol
Body Weight	3 Days	Body Weight
Heart Rate	3 Days	Heart Rate

Trial Locations

Locations (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States