Fingerprinting of Impulsivity

Impulse Control Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722174
• Other study ID #: 352.2073
• Status: Completed
• Start date: July 22, 2016
• Est. completion date: September 6, 2018

Study information

• Verified date: September 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: September 6, 2018
• Est. primary completion date: September 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Impulse Control Disorders
• Impulsive Behavior

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Antisaccade performance measured as change from baseline to follow-up visit at 4 (+/-1) weeks on the eye tracker		up to 5 weeks