Imaging the Dopamine Systems in Bulimia Nervosa | NCT01493362

Studies
Imaging the Dopamine Systems in Bulimia Nervosa

NCT01493362

Sponsor

New York State Psychiatric Institute

Status

Completed

Last Update Posted

Aug 15, 2014Estimated

Enrollment

33Actual

Phase

Not provided

Conditions

Eating Disorders

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH079397	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Dec 14, 2011

First Submission Date that Met QC Criteria

Dec 14, 2011

First Posted Date

Dec 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2014

Last Update Posted Date

Aug 15, 2014Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Label	Type	Description	Intervention Names
1		Participants with Bulimia Nervosa
2		Participants who are healthy controls

Measure	Description	Time Frame
D2 receptor density		Measured at baseline
DA release in the striatum		Measures after Mythlyphenidate challenge

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with BN:

Meets DSM-IV criteria for BN
Sufficiently medically and psychiatrically stable to participate in research

Health Control Participants:

No current or past psychiatric illness
Between 80% and 120% of ideal body weight

Exclusion Criteria:

All participants:

Current use of psychotropic medication such as anti psychotics or antidepressants
Pregnant or breastfeeding
history of substance abuse
Significant medical illness
High blood pressure (resting systolic blood pressure greater than 150mmHg and diastolic blood pressure greater that 90 mmHg)
Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV
Metal implants or paramagnetic objects contained within the body that may interfere with the MRI scan, as determined in consultation with a neuroradiologist and according to specified reference book guidelines
Exposed to radiation in the workplace or has had a nuclear medicine procedure during the 1 year before study entry
Previous adverse reaction to psycho stimulants

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

The study population will include people with bulimia nervosa seeking inpatient or outpatient treatment and people who will act as healthy control participants

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
New York State Psychiatric Institute		New York	New York	10032	United States

Condition Browse Module

MeSH Terms

ID	Term
D001068	Feeding and Eating Disorders
D052018	Bulimia Nervosa

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided