Metabolic Effects of Olanzapine in Healthy Males

NCT ID: NCT01496183

Last Updated: 2018-08-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this study is to look at how a two-week use of a medication called Olanzapine might change appetite, physical activity, resting metabolic rate, body composition, and weight in healthy men.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsule administered orally at bedtime for 14 days

Olanzapine

Group Type EXPERIMENTAL

Olanzapine

Intervention Type DRUG

Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.

Interventions

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Olanzapine

Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.

Intervention Type DRUG

Placebo

Placebo capsule administered orally at bedtime for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Volunteer
* Male
* Aged 18-35 years
* Body Mass Index (BMI): \<30 kg/m2

Exclusion Criteria

* Presence of any medical disorder that may confound the assessment of relevant biological measures
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Steven Dubovsky

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven L Dubovsky, M.D.

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

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Department of Psychiatry, The State University of New York at Buffalo

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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PCH0320106A

Identifier Type: -

Identifier Source: org_study_id

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