fMRI in Impulsivity

NCT ID: NCT02755181

Last Updated: 2018-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-22

Study Completion Date

2018-05-30

Brief Summary

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This study aims to use resting-state and task based functional Magnetic Resonance Imaging (fMRI) as a tool to evaluate trait characteristics of impulsivity in subjects with borderline personality disorder.

Detailed Description

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Conditions

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Impulse Control Disorders Borderline Personality Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BPD

Borderline Personality Disorder as diagnosed by DSM-5

Experimental

Intervention Type BEHAVIORAL

with functional imaging and behavioural measurements at baseline and 4 weeks

normal volunteers

normal volunteers

Experimental

Intervention Type BEHAVIORAL

with functional imaging and behavioural measurements at baseline and 4 weeks

Interventions

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Experimental

with functional imaging and behavioural measurements at baseline and 4 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Healthy Controls: Volunteers (age 18-50 yrs) in generally good Psychiatric and non-Psychiatric medical health
* Borderline Personality Disorder subjects: Research volunteers (age 18-50 yrs) who meet DSM-5 criteria for Borderline Personality Disorder

Exclusion Criteria

All Participants:

* Current medications which affect the central nervous system or vascular activity, such as anti-depressants, anxiolytics, or blood-pressure medications
* Positive urine drug screen for cocaine, opioids, amphetamine, and benzodiazepines
* Positive breathalyzer test for alcohol
* History of clinically significant neurologic disorders or head trauma with loss of consciousness greater than 30 minutes
* Clinically significant non-psychiatric medical disorder requiring ongoing treatment.
* Unwillingness or inability to sign a written informed consent form
* Pregnancy as assessed by a urine test for ß-HCG at each visit
* Medical or physical contraindications for participation based on medical history interview, labs, and physical exam
* Metal fragments or other bodily metal (e.g., pacemaker, orthopedic prosthesis),claustrophobia, or any other condition that would put the subjects at risk for MRI scanning

In addition, Healthy Controls excluded, if:

* DSM-5 diagnoses of Personality Disorders (based on SCID-II)
* DSM-5 diagnoses based on the SCID-I (including the eating disorders module)
* History of arrest or incarceration

In addition, Borderline Personality Disorder Subjects excluded if:

* DSM-5 diagnoses
* DSM-5 Personality Disorder other than Cluster B Personality disorders
* Current psychoactive medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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352.2067

Identifier Type: -

Identifier Source: org_study_id

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