Amino Acids, Serotonin, and Body Weight Regulation

Anorexia Nervosa Clinical Trial

Official title:

Amino Acids, Serotonin, and Body Weight Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343928
• Other study ID #: 2004P000107
• Secondary ID: R21MH0716892004P
• Status: Completed
• Phase: Phase 2
• First received: June 22, 2006
• Last updated: March 21, 2017
• Start date: June 2006

Study information

• Verified date: March 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Body Weight

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety and preoccupation with body image		Measured at Week 9
Secondary	Eating patterns		Measured at Week 9