Amino Acids, Serotonin, and Body Weight Regulation - Tabular View

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Amino Acids, Serotonin, and Body Weight Regulation

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Amino Acids, Serotonin, and Body Weight Regulation

Official Title ^†

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.

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Anorexia Nervosa

Intervention ^†

Drug: Branched-chain amino acids

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

June 2006

Completion Date

November 2008

Eligibility 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

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Devon P. Carroll, BA

617-667-4672

dcarroll@bidmc.harvard.edu

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00343928

Organization ID

R21 MH071689

Secondary IDs ^††

2004P-000107 DATR A2-AID

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

David C. Jimerson, MD

Beth Israel Deaconess Medical Center

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

February 2008

First Received Date ^†

June 22, 2006

Last Updated Date

February 28, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.