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Metabolic Effects of Olanzapine in Healthy Males

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496183
First Posted: December 21, 2011
Last Update Posted: December 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Steven Dubovsky, State University of New York at Buffalo
  Purpose
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.

Condition Intervention
Healthy Drug: Olanzapine Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Metabolic Effects of Olanzapine in Healthy Males

Resource links provided by NLM:


Further study details as provided by Steven Dubovsky, State University of New York at Buffalo:

Primary Outcome Measures:
  • Change From Baseline in Weight [ Time Frame: Assessed at baseline and 2 weeks ]

Secondary Outcome Measures:
  • Change From Baseline in Body Composition [ Time Frame: 2 weeks ]
    percent of fat vs. fat-free -or lean mass

  • Change From Baseline in 24-Hour Dietary Recall [ Time Frame: Assessed at different time points: 1 week and 2 weeks ]
  • Change From Baseline in Resting Metabolic Rate [ Time Frame: 2 weeks ]
  • Change From Baseline in Lipid Profile [ Time Frame: Assessed at different time points: 1 week and 2 weeks ]
  • Change From Baseline in Ghrelin [ Time Frame: Assessed at different time points: 1 week and 2 weeks ]
  • Change From Baseline in Glucose [ Time Frame: Assessed at different time points: 1 week and 2 weeks ]
  • Change From Baseline in Leptin [ Time Frame: Assessed at different time points: 1 week and 2 weeks ]
  • Change From Baseline in Insulin [ Time Frame: Assessed at different time points: 1 week and 2 weeks ]
  • Physical Activity [ Time Frame: 2 weeks ]
    motion monitor samples body movements

  • Change From Baseline in Appetite Sensations Using a Visual Analog Scale [ Time Frame: Assessed at different time points: 1 week and 2 weeks ]
  • Change From Baseline in Palatability of Meal Using a Visual Analog Scale [ Time Frame: Assessed at different time points: 1 week and 2 weeks ]

Enrollment: 24
Study Start Date: October 2007
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo capsule administered orally at bedtime for 14 days
Experimental: Olanzapine Drug: Olanzapine
Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496183


Locations
United States, New York
Department of Psychiatry, The State University of New York at Buffalo
Buffalo, New York, United States, 14215
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Principal Investigator: Steven L Dubovsky, M.D. The State University of New York at Buffalo
  More Information

Responsible Party: Steven Dubovsky, principal investigator, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01496183     History of Changes
Other Study ID Numbers: PCH0320106A
First Submitted: December 13, 2011
First Posted: December 21, 2011
Results First Submitted: November 24, 2014
Results First Posted: December 1, 2014
Last Update Posted: December 1, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents