NCT00343928

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

June 22, 2006

Last Update Submit

March 21, 2017

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

  • Anxiety and preoccupation with body image

    Measured at Week 9

Secondary Outcomes (1)

  • Eating patterns

    Measured at Week 9

Study Arms (1)

1

EXPERIMENTAL
Other: Branched-chain amino acids

Interventions

Branched-chain amino acidsOTHER

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.

1

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • History of anorexia nervosa
  • In normal weight range with resumed menses
  • No recent bulimic episodes
  • Persistent symptoms of anxiety

You may not qualify if:

  • Currently treated with psychotropic medication
  • Diagnosed with major depression
  • Current or recent substance dependence
  • Serious medical illness
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Amino Acids, Branched-Chain

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • David C. Jimerson, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2006

First Posted

June 23, 2006

Study Start

June 1, 2006

Primary Completion

June 1, 2008

Last Updated

March 23, 2017

Record last verified: 2017-03

Locations

US(1)