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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 16, 2007 | ||||
| Last Updated Date | September 29, 2009 | ||||
| Start Date ICMJE | June 2007 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
serotonin level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00603018 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | PET Imaging Study of Recovered Anorexics | ||||
| Official Title ICMJE | PET Imaging of Dopaminergic Transmission and Serotonin Markers in Anorexia Nervosa | ||||
| Brief Summary | Several studies in the past suggest that individuals who have or had anorexia nervosa may have alterations in brain serotonin. Serotonin seems to play an important role in regulating anxiety, mood, and other symptoms found in anorexia nervosa. We will be using a technology called Positron Emission Tomography (PET), which is a method used to take pictures of the body, in this case, the brain. Study participants will undergo two baseline PET scans on the first day of the study. They will then be given a medication called fluoxetine (also know as Prozac) to take for 8 weeks. At the end of the 8th week, they will return for a third PET scan. By comparing the brain scans, before and after fluoxetine treatment, we can understand more about how treatment with fluoxetine affects the serotonin receptors in the brain. We will be comparing brain serotonin system in women who have recovered from anorexia with healthy control women who have never had an eating disorder in order to gain a better understanding of changes in the serotonin system associated with eating disorders. This study may help shed light on how to make fluoxetine a more effective treatment for anorexia nervosa. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Basic Science, Open Label, Parallel Assignment | ||||
| Condition ICMJE | Anorexia Nervosa | ||||
| Intervention ICMJE | Drug: Fluoxetine | ||||
| Study Arms / Comparison Groups | Other: Recovered anorexia | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Estimated Completion Date | December 2008 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00603018 | ||||
| Responsible Party | Walter Kaye, MD, University of Pittsburgh Medical Center | ||||
| Study ID Numbers ICMJE | PRO06110005 | ||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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