Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

The Washington University

Status: Completed

Conditions: Hyperlipidemia; Hyperglycemia

Treatments: Drug: Olanzapine; Drug: Ziprasidone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00910988

08-0540

Details and patient eligibility

About

Primary Aim: To test the acute effects of olanzapine or ziprasidone administration, in comparison to placebo, on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min), hepatic glucose production (glucose rate of appearance [Ra]), primarily muscle glucose utilization (glucose rate of disappearance [Rd]), and adipose tissue related free fatty acid production (glycerol rate of appearance [Ra]).

We hypothesize that olanzapine, but not ziprasidone, will result in acute decreases in insulin sensitivity.

Secondary Aim: To test the acute effects of olanzapine or ziprasidone on insulin signaling pathways in antipsychotic naïve healthy young men.

We hypothesize that olanzapine, but not ziprasidone, will result in acute alterations in insulin signaling.

Full description

See brief description

Enrollment: 46 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males aged 18-45 years
• BMI approximately ≥ 25 and < 35
• insulin approximately ≥ 15 µU/ml or triglyceride approximately ≥ 130 mg/dl

Exclusion criteria

• Any DSM-IV Axis I diagnosis
• prisoners
• any serious medical disorder (i.e. metabolic diseases, type 1 or 2 diabetes mellitus, endocrine disease, coagulopathy, clinically significant anemia, acute infection)
• taking prescription medications
• non-sedentary lifestyle with > 3 hours of exercise per week

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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46 participants in 3 patient groups, including a placebo group

olanzapine

Active Comparator group

Description:

olanzapine injection in healthy control

Treatment:

Drug: Olanzapine

ziprasidone

Active Comparator group

Description:

ziprasidone injection in healthy control

Treatment:

Drug: Ziprasidone

saline

Placebo Comparator group

Description:

saline injection in healthy control

Treatment:

Drug: Ziprasidone

Drug: Olanzapine