Amino Acids, Serotonin, and Body Weight Regulation
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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 |
Other: Branched-chain amino acids |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Amino Acids, Serotonin, and Body Weight Regulation |
- Anxiety and preoccupation with body image [ Time Frame: Measured at Week 9 ] [ Designated as safety issue: No ]
- Eating patterns [ Time Frame: Measured at Week 9 ] [ Designated as safety issue: No ]
| Enrollment: | 21 |
| Study Start Date: | June 2006 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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.
|
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 |
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| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | David C. Jimerson, MD | Beth Israel Deaconess Medical Center |
More Information
No publications provided
| Responsible Party: | Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00343928 History of Changes |
| Other Study ID Numbers: | R21 MH071689, R21MH071689, 2004P-000107 DATR A2-AID |
| Study First Received: | June 22, 2006 |
| Last Updated: | February 19, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Anorexia Anorexia Nervosa Body Weight Signs and Symptoms, Digestive Signs and Symptoms Eating Disorders Mental Disorders |
Serotonin Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013