Impulse Control DisordersNCT02722174
Fingerprinting of Impulsivity
An observational study of Impulse Control Disorders, run by Boehringer Ingelheim at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Impulse Control Disorders
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2016to 6 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: subjects meeting criteria for one of the described cohorts
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23219
About this study
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
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
- Medical subject headings
- Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BED | Binge Eating Disorder | |
| ADHD | Attention Deficit Hyperactivity Disorder | |
| SUD, cocaine subtype | Stimulant Use Disorder, cocaine subtype | |
| BPD | Borderline Personality Disorder | |
| BPD, Cohort 2 | Borderline Personality Disorder, Cohort 2 | |
| HC | Healthy Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/No Go Task
Measured: 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
Measured: up to 5 weeks
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Computerized Monetary Choice Task
Measured: 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)
Measured: 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)
Measured: 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
Measured: up to 5 weeks
Secondary outcomes (1)
Antisaccade performance measured as change from baseline to follow-up visit at 4 (+/-1) weeks on the eye tracker
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start22 Jul 2016
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impulse Control DisordersStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722174
- Sponsor's protocol ID
- 352.2073
- Status last verified
- Sep 2018
- First submitted
- 23 Mar 2016
- Last updated
- 13 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02722174
- Acronym / sponsor ID
- 352.2073
- Conditions
- Impulse Control Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BED | – | –Binge Eating Disorder |
| ADHD | – | –Attention Deficit Hyperactivity Disorder |
| SUD, cocaine subtype | – | –Stimulant Use Disorder, cocaine subtype |
| BPD | – | –Borderline Personality Disorder |
| BPD, Cohort 2 | – | –Borderline Personality Disorder, Cohort 2 |
| HC | – | –Healthy Controls |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- subjects meeting criteria for one of the described cohorts
Key inclusion criteria (12 listed)
- Males and females ages 18-50.
- Volunteers in generally good Psychiatric and non-Psychiatric medical health
- Subjects who meet Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria for Borderline Personality Disorder
- Subjects who meet DSM-V criteria for Binge Eating Disorder.
- Subjects who meet DSM-V criteria for current Stimulant Use Disorder, subtype cocaine, moderate or severe use
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/No Go Task
Time frame: 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
Time frame: up to 5 weeks
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Computerized Monetary Choice Task
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: up to 5 weeks
1 secondary outcome
Antisaccade performance measured as change from baseline to follow-up visit at 4 (+/-1) weeks on the eye tracker
Time frame: up to 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impulse Control Disorders, run by Boehringer Ingelheim at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/No Go Task (time frame: up to 5 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.