NCT00978666

Brief Summary

The purpose of this study is to use fMRI imaging technology to examine areas in the brain related to appetite, reward and cognition in adolescent women with eating disorders as compared to those who have never had an eating disorder. Better understanding biologic vulnerabilities in women with anorexia is essential for developing more effective treatment options.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

2.2 years

First QC Date

September 16, 2009

Last Update Submit

November 12, 2019

Conditions

Study Arms (2)

Healthy controls

Healthy comparison adolescent females

Anorexia Nervosa

Adolescent females currently ill with Anorexia Nervosa, restricting type

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants with anorexia nervosa will be selected from the community as well as from local medical clinics and eating disorder treatment centers. Healthy volunteers will be selected from the community at large.

You may qualify if:

  • Female
  • Ages 12-18
  • Right Handed
  • Active AN diagnosis (within last 6 months), excluding amenorrhea criteria

You may not qualify if:

  • Male
  • Left Handed
  • Does not meet AN criteria within last 6 months
  • Alcohol/drug dependence in the 3 months prior to study
  • Alcohol/drug use within the 30 days prior to scan. Tox Screen will be administered at GCRC.
  • Use of antipsychotic medication in 3 months prior to study (SSRI OK)
  • Current diagnosis of severe major effective d/o or anxiety d/o or other psychopathology that might interfere with ability to participate e.g requiring inpatient hospitalization or medication
  • Pregnancy or lactation
  • Organic brain syndromes, dementia, psychotic disorders or mental retardation
  • Neurological or medical disorders such as seizure disorder, renal disease including pyelonephritis and chronic cystitis, impaired renal function including hyponatremia (less than 135meq/l), hypokalemia, raised BUN (more than 15mg/dl), diabetes, thyroid disease (hypo and hyper), EKG indicative of electrolyte imbalance
  • Lack of effective birth control during 15 days before the scan. A Urine pregnancy test will be conducted within 24 hours of the scan
  • Insufficient English
  • Female
  • Ages 12-18
  • Right Handed
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Eating Disorder Treatment and Research Program

La Jolla, California, 92037, United States

Location

Related Links

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 16, 2009

First Posted

September 17, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2011

Study Completion

November 1, 2019

Last Updated

November 14, 2019

Record last verified: 2019-11

Locations