Anorexia NervosaNCT00325520
A Neurocognitive Model of Anorexia Nervosa
An observational study of Anorexia Nervosa, run by New York State Psychiatric Institute.
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… Read more about this study
- Who is it for?
- Ages 16 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- May 2006to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with Anorexia Nervosa or Healthy Volunteers
Who may be able to join
- DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype), current or prior;
- Age 16-45;
- Inpatient on GCRU
- Medically stable.
- No current or past psychiatric illness;
- Age 16-45
- No history of binge eating or vomiting;
- Normal weight (80%-120% ideal body weight)
Who cannot join
- 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:
- Significant medical or neurologic illness(concussion, seizure disorder, learning disability, other neurological illness)
Show all 13Show fewer
- 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
About this study
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.
Read the detailed 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.
- Conditions
- Anorexia Nervosa
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anorexia nervosa | Individuals with anorexia nervosa receiving inpatient treatment | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological functioning
Measured: pre- and post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Klarman Family Foundation, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Joanna Steinglass, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325520
- Sponsor's protocol ID
- #5984R
- Other IDs
- K23MH076195-01A2
- Status last verified
- Jul 2013
- First submitted
- 12 May 2006
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neurocognitive Model of Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00325520
- Acronym / sponsor ID
- #5984R
- Conditions
- Anorexia Nervosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Klarman Family Foundation, National Institute of Mental Health (NIMH)
- Study start
- May 2006
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorexia nervosa | – | –Individuals with anorexia nervosa receiving inpatient treatment |
| Healthy controls | – | – |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with Anorexia Nervosa or Healthy Volunteers
Key inclusion criteria (8 listed)
- DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype), current or prior;
- Age 16-45;
- Inpatient on GCRU
- Medically stable.
- No current or past psychiatric illness;
Key exclusion criteria (13 listed)
- 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
- Significant medical or neurologic illness(concussion, seizure disorder, learning disability, other neurological illness)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuropsychological functioning
Time frame: pre- and post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Steinglass, MD principal investigator
New York State Psychiatric Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by New York State Psychiatric Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological functioning (time frame: pre- and post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.