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fMRI in Impulsivity

Boehringer Ingelheim logo

Boehringer Ingelheim

Status

Completed

Conditions

Borderline Personality Disorder
Impulse Control Disorders

Treatments

Behavioral: Experimental

Study type

Observational

Funder types

Industry

Identifiers

NCT02755181
352.2067

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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
  • Further exclusion criteria apply

Trial design

48 participants in 2 patient groups

BPD
Description:
Borderline Personality Disorder as diagnosed by DSM-5
Treatment:
Behavioral: Experimental
normal volunteers
Description:
normal volunteers
Treatment:
Behavioral: Experimental

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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