Fingerprinting of Impulsivity

Completed

Conditions studied: Impulse Control Disorders

In brief

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.

Key facts

Study ID

NCT02722174

Run by

Boehringer Ingelheim

People needed

141

Starts

2016-07-22

Expected to finish

2018-09-06

Last updated by the study team

2018-09-13

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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:
• 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).

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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