Fingerprinting of Impulsivity

NCT ID: NCT02722174

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 141 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-22
• Study Completion Date: 2018-09-06

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

BED

Binge Eating Disorder

No interventions assigned to this group

ADHD

Attention Deficit Hyperactivity Disorder

No interventions assigned to this group

SUD, cocaine subtype

Stimulant Use Disorder, cocaine subtype

No interventions assigned to this group

BPD

Borderline Personality Disorder

No interventions assigned to this group

BPD, Cohort 2

Borderline Personality Disorder, Cohort 2

No interventions assigned to this group

HC

Healthy Controls

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

352.2073

Identifier Type: -

Identifier Source: org_study_id