Impulse Control Disorders
Conditions
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.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 Urgency, Premeditation, Perseverance, Sensation Seeking and Positive Urgency (UPPs-P) Impulsive Behavior Scale | 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 |
Secondary
| 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 |
Countries
United States
Outcome results
None listed