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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00836251 |
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Date of registration:
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03/02/2009 |
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Primary sponsor: |
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Public title:
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Effects of Antipsychotic Medications on Energy Intake and Expenditure
DLW |
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Scientific title:
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Effects of Antipsychotic Medications on Energy Intake and Expenditure |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00836251 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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John W Newcomer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Miami |
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Name:
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Ginger Nicol, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- non-diabetic
- schizophrenic or schizoaffective
- currently prescribed olanzapine or ziprasidone
- 18-80 y.o.
Exclusion Criteria:
- <18 or >80 years of age
- diabetic
- not schizophrenic or schizoaffective
- not currently prescribed olanzapine or ziprasidone
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schizoaffective Disorder
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Schizophrenia
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Weight Gain
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Intervention(s)
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Dietary Supplement: H218O and 2H2O, administered as a mixed cocktail
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Primary Outcome(s)
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treatment-induced changes in Total Energy Expenditure (TEE), Activity Energy Expenditure (AEE), and Energy Intake (EI)
[Time Frame: 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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