Amino Acids, Serotonin, and Body Weight Regulation

Condition(s) targeted: Anorexia Nervosa

Intervention: Branched-chain amino acids (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Beth Israel Deaconess Medical Center

Official(s) and/or principal investigator(s):
David C. Jimerson, MD, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center

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.

Official title: Amino Acids, Serotonin, and Body Weight Regulation

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Anxiety and preoccupation with body image

Secondary outcome: Eating patterns

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.

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Starting date: June 2006
Last updated: February 19, 2013