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

Penn State Health logo

Penn State Health

Status

Completed

Conditions

Diabetes Mellitus
Insulin Resistance

Treatments

Drug: Olanzapine 10 mg po qhs for 3 days
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

15 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo
Olanzapine
Experimental group
Description:
Olanzapine 10mg po daily x 3 days
Treatment:
Drug: Olanzapine 10 mg po qhs for 3 days

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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