fMRI in Impulsivity

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