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Metabolic Effects of Olanzapine in Healthy Males

This study is currently recruiting participants.
Verified December 2011 by State University of New York at Buffalo
Sponsor:
Information provided by (Responsible Party):
Steven Dubovsky, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01496183
First received: December 13, 2011
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  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 Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Metabolic Effects of Olanzapine in Healthy Males

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change from Baseline in Weight [ Time Frame: Assessed at different time points: 1 week and 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Body Composition [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change from Baseline in Resting Metabolic Rate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Lipid Profile [ Time Frame: Assessed at different time points: 1 week and 2 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Ghrelin [ Time Frame: Assessed at different time points: 1 week and 2 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Glucose [ Time Frame: Assessed at different time points: 1 week and 2 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Leptin [ Time Frame: Assessed at different time points: 1 week and 2 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Insulin [ Time Frame: Assessed at different time points: 1 week and 2 weeks ] [ Designated as safety issue: No ]
  • Physical Activity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change from Baseline in Palatability of Meal using a Visual Analog Scale [ Time Frame: Assessed at different time points: 1 week and 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496183

Locations
United States, New York
Department of Psychiatry, The State University of New York at Buffalo Recruiting
Buffalo, New York, United States, 14215
Contact: Elsa C Daurignac, Ph.D.     716-898-4540     ecd3@buffalo.edu    
Principal Investigator: Steven L Dubovsky, M.D.            
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

No publications provided

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
Study First Received: December 13, 2011
Last Updated: December 20, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013