Fingerprinting of Impulsivity

NCT02722174 | Completed

• 1 other identifier: 352.2073
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to examine a battery of behavioral and questionnaire measures in 4 disorders clinically associated with impulsivity and in health controls, to: 1) investigate if the different populations have a distinct behavioral profile, and 2) to investigate if there are specific measures that are reliable and sensitive measures of impulsivity across diagnoses.

Conditions

Impulse Control Disorders

Outcome Measures

Primary Outcomes (6)

• Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/No Go Task

  up to 5 weeks

• Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Stop Signal Reaction Time (SSRT) Task

  up to 5 weeks

• Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Computerized Monetary Choice Task

  up to 5 weeks

• Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Barratt Impulsiveness Questionnaire version 11 (BIS-11)

  up to 5 weeks

• Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Immediate Memory Task (IMT)

  up to 5 weeks

• Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Urgency, Premeditation, Perseverance, Sensation Seeking and Positive Urgency (UPPs-P) Impulsive Behavior Scale

  up to 5 weeks

Secondary Outcomes (1)

• Antisaccade performance measured as change from baseline to follow-up visit at 4 (+/-1) weeks on the eye tracker

  up to 5 weeks

Study Arms (6)

BED

Binge Eating Disorder

ADHD

Attention Deficit Hyperactivity Disorder

SUD, cocaine subtype

Stimulant Use Disorder, cocaine subtype

BPD

Borderline Personality Disorder

BPD, Cohort 2

Borderline Personality Disorder, Cohort 2

HC

Healthy Controls

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

subjects meeting criteria for one of the described cohorts

You may qualify if:

• All cohorts:
• \- Males and females ages 18-50.
• Healthy Control cohort:
• \- Volunteers in generally good Psychiatric and non-Psychiatric medical health
• Borderline Personality Disorder (2 cohorts):
• \- Subjects who meet Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria for Borderline Personality Disorder
• Binge Eating Disorder cohort:
• \- Subjects who meet DSM-V criteria for Binge Eating Disorder.
• Stimulant Use Disorder cohort:
• \- Subjects who meet DSM-V criteria for current Stimulant Use Disorder, subtype cocaine, moderate or severe use
• Attention Deficit Hyperactivity Disorder cohort:
• \- Subjects who meet DSM-V criteria for adult Attention Deficit Hyperactivity Disorder

You may not qualify if:

• General:
• Positive breathalyzer test for alcohol at any study visit
• 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 as judged by the investigator.
• Unwillingness or inability to sign a written informed consent form
• Pregnancy as assessed by a urine test for ß-Human Chorionic Gonadotropin (ß-HCG) at screening visit
• Medical or physical contraindications for participation (see below), based on medical history interview, as judged by the investigator
• Unwilling to refrain from tobacco use one hour prior to testing until after conclusion of testing
• Healthy Controls:
• Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnoses of Personality Disorders (based on Structured Clinical Interview for DSM-IV (SCID)-II)
• DSM-5 diagnoses based on the SCID-I (including the eating disorders and Attention Deficit Hyperactivity Disorder (ADHD) module)
• History of arrest or incarceration
• Positive urine drug screen for cannabis, cocaine, opioids, amphetamine, and benzodiazepines at any visit
• Current Tobacco Users
• Borderline Personality Disorder Subjects:

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Disruptive, Impulse Control, and Conduct Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 29, 2016
• Study Start: July 22, 2016
• Primary Completion: September 6, 2018
• Study Completion: September 6, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

US (1)