NCT03450239

Brief Summary

The investigators will examine compulsivity in those who have recovered from anorexia nervosa, using a multi-modal MRI study. The neural activation of key fronto-striatal areas will be explored using a task which examines set-shifting and reversal-learning, two key components of compulsivity. Additionally, the functional networks displayed during resting-state MRI will be examined between groups, as will the neurochemicals present (using Magnetic Resonance spectroscopy).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

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

May 5, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

9 months

First QC Date

February 15, 2018

Last Update Submit

April 3, 2018

Conditions

Keywords

MRI

Outcome Measures

Primary Outcomes (1)

  • Blood Oxygen-Level Dependent (BOLD) signal whilst performing set-shifting and reversal-learning

    BOLD signal differences between groups during the set-shifting and reversal-learning elements of a task: will be examined in orbitofrontal cortex, dorsolateral prefrontal cortex, and striatum. Analyse using a repeated measures ANOVA with region as within-subject factor and group as between-subject factor. Follow up significant interactions with paired t-tests.

    1 day (During MRI scan)

Secondary Outcomes (4)

  • Differences between groups in the connectivity of the fronto-parietal and default mode networks using independent components analysis, dual regression and permutation testing across the brain.

    1 day (During MRI scan)

  • The correlation of the default mode network and frontoparietal network activity with perseverative errors on the Wisconsin Card Sorting Task across groups

    1 day (During MRI scan)

  • Investigate a difference in levels of glutamate between groups

    1 day (During MRI scan)

  • Examine differences between groups on an impulsivity measure

    1 day (During MRI scan)

Study Arms (2)

Recovered from anorexia nervosa

EXPERIMENTAL

Women who have recovered from Anorexia Nervosa for over a year. BMI over 18.5, aged 18-40, scores on Eating Disorder Examination (EDE) within 1 standard deviation of the global mean. All these participants undergo an MRI scan.

Other: MRI

Healthy controls

EXPERIMENTAL

Healthy control women. BMI over 18.5, aged 18-40, scores on EDE within 1 standard deviation of the global mean. All these participants undergo an MRI scan.

Other: MRI

Interventions

MRIOTHER

MRI scan, including structural imaging, functional imaging (both task-related and structural), and Magnetic Resonance Spectroscopy.

Healthy controlsRecovered from anorexia nervosa

Eligibility Criteria

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

You may qualify if:

  • Able and willing to give informed consent
  • BMI over 18.5 and has remained so for the last year
  • Score lower than mean+1 standard deviation of global mean scores for young women on the EDE
  • Fluent English speaker
  • Former diagnosis of anorexia nervosa in relevant group

You may not qualify if:

  • Any current diagnosis of a psychiatric disorder which in the investigator's opinion could impact study results (e.g. significant depression, anxiety or OCD).
  • Any current psychotropic medications.
  • Eyesight problems that would prohibit participating in a task-fMRI study.
  • Current regular cigarette smoking of over 5 cigarettes per day.
  • Recent use of illicit drugs.
  • Alcohol intake which indicates an element of alcohol abuse; or unwillingness to refrain from drinking the night before the study visit.
  • Any contraindications to MRI scanning (including claustrophobia).
  • Participant is pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, University of Oxford

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

Related Publications (3)

  • Chamberlain SR, Menzies L, Hampshire A, Suckling J, Fineberg NA, del Campo N, Aitken M, Craig K, Owen AM, Bullmore ET, Robbins TW, Sahakian BJ. Orbitofrontal dysfunction in patients with obsessive-compulsive disorder and their unaffected relatives. Science. 2008 Jul 18;321(5887):421-2. doi: 10.1126/science.1154433.

    PMID: 18635808BACKGROUND
  • Boehm I, Geisler D, King JA, Ritschel F, Seidel M, Deza Araujo Y, Petermann J, Lohmeier H, Weiss J, Walter M, Roessner V, Ehrlich S. Increased resting state functional connectivity in the fronto-parietal and default mode network in anorexia nervosa. Front Behav Neurosci. 2014 Oct 2;8:346. doi: 10.3389/fnbeh.2014.00346. eCollection 2014.

    PMID: 25324749BACKGROUND
  • Godlewska BR, Pike A, Sharpley AL, Ayton A, Park RJ, Cowen PJ, Emir UE. Brain glutamate in anorexia nervosa: a magnetic resonance spectroscopy case control study at 7 Tesla. Psychopharmacology (Berl). 2017 Feb;234(3):421-426. doi: 10.1007/s00213-016-4477-5. Epub 2016 Dec 1.

    PMID: 27909746BACKGROUND

MeSH Terms

Conditions

Compulsive Behavior

Condition Hierarchy (Ancestors)

Impulsive BehaviorBehavior

Study Officials

  • Philip J Cowen, Prof

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: All participants undero go an MRI scan, complete some questionnaires and two computer tasks. Participants are in two groups: those who have recovered from anorexia nervosa, and healthy control participants.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

March 1, 2018

Study Start

May 5, 2017

Primary Completion

February 7, 2018

Study Completion

February 7, 2018

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations