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Amino Acids, Serotonin, and Body Weight Regulation
This study has been completed.
Study NCT00343928   Information provided by National Institute of Mental Health (NIMH)
First Received: June 22, 2006   Last Updated: May 29, 2009   History of Changes

June 22, 2006
May 29, 2009
June 2006
June 2008   (final data collection date for primary outcome measure)
Anxiety and preoccupation with body image [ Time Frame: Measured at Week 9 ] [ Designated as safety issue: No ]
Anxiety and preoccupation with body image
Complete list of historical versions of study NCT00343928 on ClinicalTrials.gov Archive Site
Eating patterns [ Time Frame: Measured at Week 9 ] [ Designated as safety issue: No ]
Eating patterns
 
Amino Acids, Serotonin, and Body Weight Regulation
Amino Acids, Serotonin, and Body Weight Regulation

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.

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.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment
Anorexia Nervosa
Other: Branched-chain amino acids
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
21
 
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of anorexia nervosa
  • In normal weight range with resumed menses
  • No recent bulimic episodes
  • Persistent symptoms of anxiety

Exclusion Criteria:

  • Currently treated with psychotropic medication
  • Diagnosed with major depression
  • Current or recent substance dependence
  • Serious medical illness
  • Pregnant or breastfeeding
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00343928
Dr. David Jimerson, Study Principal Investigator, Beth Israel Deaconess Medical Center
R21 MH071689, 2004P-000107 DATR A2-AID
National Institute of Mental Health (NIMH)
 
Principal Investigator: David C. Jimerson, MD Beth Israel Deaconess Medical Center
National Institute of Mental Health (NIMH)
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP