A Neurocognitive Model of Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

A Neurocognitive Model of Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325520
• Other study ID #: #5984R
• Secondary ID: K23MH076195-01A2
• Status: Completed
• Phase: N/A
• First received: May 12, 2006
• Last updated: August 14, 2014
• Start date: May 2006
• Est. completion date: May 2014

Study information

• Verified date: July 2013
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate thought processes and neural mechanisms that may contribute to the development of habitual behaviors. The investigators hypothesize that patients with AN will perform differently than people without eating disorders on a series of neuropsychological tasks and will show different neural activation patterns in functional neuroimaging scans.

Description:

Patients with Anorexia Nervosa (AN) have extreme difficulty changing their eating behavior, even when they express desire for change. These behaviors seem to override all other potential responses, and can appear perseverative, or habitual. The purpose of this study is to investigate thought processes and neural mechanisms that may contribute to the development of habitual behaviors. The investigators hypothesize that patients with AN will perform differently than people without eating disorders on a series of neuropsychological tasks and will show different neural activation patterns in functional neuroimaging scans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 45 Years

Eligibility

Inclusion:

• DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype), current or prior;

• Age 16-45;

• Inpatient on GCRU

• Medically stable.

Exclusion:

• Any other current major Axis I disorder (including current bulimia nervosa), except major depression;

• History of concussion, seizure disorder, or other neurological illness;

• History of learning disability;

• Acute Suicidality

Healthy comparison group:

Inclusion:

• No current or past psychiatric illness;

• Age 16-45

• No history of binge eating or vomiting;

• Normal weight (80%-120% ideal body weight)

Exclusion:

• Significant medical or neurologic illness(concussion, seizure disorder, learning disability, other neurological illness)

• Current psychotropic medication or medications known to impact cognition

Additional Exclusion Criteria for fMRI:

• Significant Claustrophobia

• Pregnancy

• Indwelling metallic object, non-removable metal jewelry, medicinal patch or recent metallic ink tattoo

• For patients, current psychotropic medications (antidepressants for 2 week (prozac and antipsychotics for 4 weeks)

• For patients, any other current Axis I diagnosis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Klarman Family Foundation, National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological functioning		pre- and post-treatment	No