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Amino Acids, Serotonin, and Body Weight Regulation

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), February 2008

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  

U.S. FDA Resources

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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Anxiety and preoccupation with body image [ Time Frame: Measured at Week 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Eating patterns [ Time Frame: Measured at Week 9 ] [ Designated as safety issue: No ]

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.

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.

  Eligibility
Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343928

Contacts
Contact: Devon P. Carroll, BA     617-667-4672     dcarroll@bidmc.harvard.edu    

Locations
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    

Sponsors and Collaborators

Investigators
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

Study placed in the following topic categories:
Body Weight
Anorexia
Anorexia Nervosa
Serotonin
Eating Disorders

Additional relevant MeSH terms:
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on July 03, 2008




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