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| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00343928 |
Purpose
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.
| Condition | Intervention | Phase |
|
Anorexia Nervosa |
Drug: Branched-chain amino acids |
Phase II |
| ChemIDplus related topics: | Serotonin Amino acids, branched-chain |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment |
| Official Title: | Amino Acids, Serotonin, and Body Weight Regulation |
| Estimated Enrollment: | 15 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | November 2008 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: Branched-chain amino acids
Participants will spend approximately 2 weeks in each phase over a 9-week period, during which they will receive an amino acid mixture and the placebo control condition.
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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.
Eligibility
| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Devon P. Carroll, BA | 617-667-4672 | dcarroll@bidmc.harvard.edu |
| United States, Massachusetts | |||||
| Beth Israel Deaconess Medical Center | Recruiting | ||||
| Boston, Massachusetts, United States, 02215 | |||||
| Contact: Devon P. Carroll, BA 617-667-4672 dcarroll@bidmc.harvard.edu | |||||
| Principal Investigator: | David C. Jimerson, MD | Beth Israel Deaconess Medical Center |
More Information
| Responsible Party: | Beth Israel Deaconess Medical Center ( Dr. David Jimerson, Study Principal Investigator ) |
| Study ID Numbers: | R21 MH071689, 2004P-000107 DATR A2-AID |
| First Received: | June 22, 2006 |
| Last Updated: | February 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00343928 |
| Health Authority: | United States: Federal Government |
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