Fingerprinting of Impulsivity

Fingerprinting of Impulsivity in Four Diagnostic and Statistical Manual of Mental Disorders, Version 5 (DSM-5) Psychiatric Disorders That Have Been Clinically Associated With Impulsivity Using a Battery of Questionnaires and Behavioral Laboratory Tests

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.

Study Overview

• Status: Completed
• Conditions: Impulse Control Disorders

• Study Type: Observational
• Enrollment (Actual): 141

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

subjects meeting criteria for one of the described cohorts

Description

Inclusion criteria:

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

Exclusion criteria:

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:

• DSM-5 diagnoses other than: Tobacco Use Disorder, Major Depressive Disorder (Mild Subtype), Generalized Anxiety Disorder (in remission), Post-Traumatic Stress Disorder (in remission), Major Depressive Disorder (Moderate or Severe Subtype, in remission), or Substance use disorder (Mild subtype, in remission)
• DSM-5 Personality Disorder other than Cluster B Personality disorders.
• Positive urine drug screen for cocaine, opioids, amphetamine, and benzodiazepines at any visit
• Antipsychotic medication or mood stabilizers taken within the last 30 days or change in antidepressant medication within the last 30 days.

Binge Eating Disorder Subjects:

• DSM-5 diagnoses other than: Binge Eating Disorder (current bulimia also excluded), Tobacco Use Disorder, Major Depressive Disorder (in remission), Generalized Anxiety Disorder (in remission), Post-Traumatic Stress Disorder (in remission), and Substance Use Disorder (in remission, mild subtype).
• DSM-5 diagnoses of Cluster B Personality disorders.
• Positive urine drug screen for cocaine, opioids, amphetamine, and benzodiazepines at any visit

Stimulant Use Disorder, Cocaine Subtype Subjects:

• DSM-5 diagnoses other than: Stimulant Use Disorder, Cannabis Use Disorder, Alcohol Use Disorder (Mild Subtype), and Tobacco Use Disorder, Substance Induced Mood Disorder, Major Depressive Disorder (in remission), Generalized Anxiety Disorder (in remission), Post-Traumatic Stress Disorder (in remission).
• DSM-5 diagnoses of Cluster B Personality Disorders.
• Positive urine drug screen for opioids, amphetamine, and benzodiazepines at any visit

ADHD Subjects:

• DSM-5 diagnoses other than ADHD, Substance Induced Mood Disorder, Major Depressive Disorder (in remission), Generalized Anxiety Disorder (in remission), Post-Traumatic Stress Disorder (in remission), Substance Use Disorder (mild subtype, in remission).
• DSM-5 diagnoses of Cluster B Personality Disorders.
• Stimulant medication taken the morning of behavioral testing.
• Positive urine drug screen for cannabis, cocaine, opioids, amphetamine, methamphetamine or benzodiazepines at any visit. Subjects with a valid prescription for amphetamines for the treatment of ADHD will not be excluded.
• Unable or unwilling to withhold medications prescribed for treatment of ADHD on the morning of any behavioral testing clinic visit.
• Further exclusion criteria apply

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
HC; Healthy Controls
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Antisaccade performance measured as change from baseline to follow-up visit at 4 (+/-1) weeks on the eye tracker	up to 5 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2016
• Primary Completion (Actual): September 6, 2018
• Study Completion (Actual): September 6, 2018

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 29, 2016

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Impulsive Behavior; Disruptive, Impulse Control, and Conduct Disorders
• Other Study ID Numbers: 352.2073