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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00368667 |
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Date of registration:
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24/08/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Energy Homeostasis in Anorexia Nervosa
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Scientific title:
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Energy Homeostasis in Anorexia Nervosa |
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Date of first enrolment:
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April 2000 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00368667 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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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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Laurel Mayer, 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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New York State Psychiatric Institute |
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Key inclusion & exclusion criteria
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Patients:
Inclusion Criteria:
- DSM-IV diagnosis of Anorexia Nervosa
- BMI = 17.5kg/m2 (equivalent to 80% of ideal body weight)
- Medically stable
- Participation in in-patient treatment sufficient to restore patient to a BMI of at
least 19kg/m2
Exclusion Criteria:
- On medication*
- Current substance abuse or dependence
- History of suicide attempt or other self-injurious behavior within the previous 6
months
- Non-removable metal on/in their body (e.g. metal pacemaker, surgical clips,
metallic-ink tattoos)
Controls:
Inclusion criteria:
- No current psychiatric disorder (including eating disorder, depression, bipolar
disorder, schizophrenia, substance abuse/dependence)
- No history of an eating disorder
- BMI greater than 19kg/m2 and less than 21kg/m2
- Weight stable (+/- 2kg) for the previous 6 months
- No history of excessive or repeated dieting
- No history of excessive exercise (defined as greater than 6 hours/week)
- Regular menstrual cycles
Exclusion criteria:
- On medication*
- Pregnant or lactating
- Significant medical problem
- Non-removable metal on/in their body (e.g. metal pacemaker, surgical clips,
metallic-ink tattoos)
- At the time of testing, subjects will be free of fluoxetine for 6 weeks, and
free of all other medications for a minimum of 2 weeks
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Anorexia Nervosa
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Secondary ID(s)
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DK 02749 (completed)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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