Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus

NCT00351000

Schizophrenia

COMPLETED PHASE4

Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder

NCT00190749

Schizophrenia Schizoaffective Disorder

COMPLETED PHASE4

Intranasal Insulin and Olanzapine Study in Healthy Volunteers

NCT03741478

Healthy Controls

UNKNOWN PHASE1

Effects of Antipsychotic Medications on Energy Intake and Expenditure

NCT00836251

Schizophrenia Schizoaffective Disorder Weight Gain

COMPLETED

Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia.

NCT00239109

Schizophrenia

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

See brief description

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperglycemia Hyperlipidemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

olanzapine

olanzapine injection in healthy control

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

olanzapine/Zyprexa

ziprasidone

ziprasidone injection in healthy control

Group Type ACTIVE_COMPARATOR

Ziprasidone

Intervention Type DRUG

ziprasidone/Geodon

saline

saline injection in healthy control

Group Type PLACEBO_COMPARATOR

Olanzapine

Intervention Type DRUG

olanzapine/Zyprexa

Ziprasidone

Intervention Type DRUG

ziprasidone/Geodon

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Olanzapine

olanzapine/Zyprexa

Intervention Type DRUG

Ziprasidone

ziprasidone/Geodon

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zyprexa Geodon

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes