Fingerprinting of Impulsivity

Boehringer Ingelheim

Status

Completed

Conditions

Impulse Control Disorders

Study type

Observational

Funder types

Industry

Identifiers

NCT02722174

352.2073

Details and patient eligibility

About

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.

Enrollment

141 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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