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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 22, 2006 | ||||
| Last Updated Date | May 29, 2009 | ||||
| Start Date ICMJE | June 2006 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Anxiety and preoccupation with body image [ Time Frame: Measured at Week 9 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Anxiety and preoccupation with body image | ||||
| Change History | Complete list of historical versions of study NCT00343928 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Eating patterns [ Time Frame: Measured at Week 9 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Eating patterns | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Amino Acids, Serotonin, and Body Weight Regulation | ||||
| Official Title ICMJE | Amino Acids, Serotonin, and Body Weight Regulation | ||||
| Brief Summary | This study will assess the behavioral effects of an amino acid mixture thought to influence serotonin function in individuals who have recovered from anorexia nervosa. |
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| Detailed Description | Anorexia nervosa is a serious psychiatric disorder resulting in psychosocial distress for patients and their families, potentially severe medical consequences, and substantial long-term mortality. A major emphasis in current therapeutic research in anorexia nervosa is exploration of new interventions to stabilize recovery and prevent relapse. Although the etiology of anorexia nervosa is unknown, altered regulation of the neurotransmitter serotonin in the central nervous system is thought to contribute to preoccupation with body shape and weight, dysregulated eating patterns, persistent anxiety, and frequent mood fluctuations. The goal of this exploratory project is to assess the behavioral effects of an amino acid mixture thought to influence serotonin function in individuals who have recovered from anorexia nervosa. It is hypothesized that this brief intervention will help diminish residual eating disorder symptoms. All participants in this crossover study will attend eight sessions over a 9-week period. Participants will spend approximately 2 weeks in each phase, during which they will receive an amino acid mixture and the control condition. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment | ||||
| Condition ICMJE | Anorexia Nervosa | ||||
| Intervention ICMJE | Other: Branched-chain amino acids | ||||
| Study Arms / Comparison Groups | |||||
| 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 | Completed | ||||
| Enrollment ICMJE | 21 | ||||
| Completion Date | |||||
| Primary Completion Date | June 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 40 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00343928 | ||||
| Responsible Party | Dr. David Jimerson, Study Principal Investigator, Beth Israel Deaconess Medical Center | ||||
| Study ID Numbers ICMJE | R21 MH071689, 2004P-000107 DATR A2-AID | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | May 2009 | ||||
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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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