Impulse Control DisordersNCT02755181
fMRI in Impulsivity
An observational study of Impulse Control Disorders and Borderline Personality Disorder, run by Boehringer Ingelheim at 1 site in United States.
Trial summary
This study aims to use resting-state and task based functional Magnetic Resonance Imaging (fMRI) as a tool to evaluate trait characteristics of impulsivity in subjects with borderline personality disorder. 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, Borderline Personality Disorder
- What is being tested?
- Experimental
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2016to 30 May 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: BPD and normal volunteers
Who may be able to join
- Healthy Controls: Volunteers (age 18-50 yrs) in generally good Psychiatric and non-Psychiatric medical health
- Borderline Personality Disorder subjects: Research volunteers (age 18-50 yrs) who meet DSM-5 criteria for Borderline Personality Disorder
Who cannot join
- All Participants:
- Current medications which affect the central nervous system or vascular activity, such as anti-depressants, anxiolytics, or blood-pressure medications
- Positive urine drug screen for cocaine, opioids, amphetamine, and benzodiazepines
- Positive breathalyzer test for alcohol
- 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.
Show all 19Show fewer
- Unwillingness or inability to sign a written informed consent form
- Pregnancy as assessed by a urine test for ß-HCG at each visit
- Medical or physical contraindications for participation based on medical history interview, labs, and physical exam
- Metal fragments or other bodily metal (e.g., pacemaker, orthopedic prosthesis),claustrophobia, or any other condition that would put the subjects at risk for MRI scanning
- In addition, Healthy Controls excluded, if:
- DSM-5 diagnoses of Personality Disorders (based on SCID-II)
- DSM-5 diagnoses based on the SCID-I (including the eating disorders module)
- History of arrest or incarceration
- In addition, Borderline Personality Disorder Subjects excluded if:
- DSM-5 diagnoses
- DSM-5 Personality Disorder other than Cluster B Personality disorders
- Current psychoactive medications
- 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: Assessment of Longitudinal Functional Magnetic Resonance Imaging (fMRI) as a Brain Measure for Impulsivity in a Borderline Personality Disorder (BPD) Model
This study aims to use resting-state and task based functional Magnetic Resonance Imaging (fMRI) as a tool to evaluate trait characteristics of impulsivity in subjects with borderline personality disorder.
- Being tested
- Experimental
- Medical subject headings
- Disruptive, Impulse Control, and Conduct Disorders, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalBehavioural
with functional imaging and behavioural measurements at baseline and 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| BPD | Borderline Personality Disorder as diagnosed by DSM-5 Receives: Behavioral: Experimental | |
| normal volunteers | normal volunteers Receives: Behavioral: Experimental |
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 Affective Faces Task (AFT) fMRI response
Measured: up to 5 weeks
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Monetary Incentive Delay (MID) fMRI task response
Measured: up to 5 weeks
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for resting-state functional magnetic resonance imaging (fMRI) activity
Measured: up to 5 weeks
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/ No Go functional magnetic resonance imaging (fMRI) response
Measured: up to 5 weeks
Secondary outcomes (11)
Change from baseline to 4 week follow-up visit for Eye Tracking
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) behavioral test
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 procedure behavioral test
Measured: up to 5 weeks
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Stop-signal paradigm behavioral test
Measured: up to 5 weeks
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Barratt Impulsiveness Scale v.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 Profile of Mood States behavioral test
Measured: 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 behavioral test
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, subscale for premeditation
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, subscale for perseverance
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, subscale for sensation seeking
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, subscale for urgency
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 posted28 Apr 2016 (estimated)
- Study start22 Jul 2016
- Primary completion30 May 2018
- Study completion30 May 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
- 48 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
- NCT02755181
- Sponsor's protocol ID
- 352.2067
- Status last verified
- Aug 2018
- First submitted
- 8 Apr 2016
- Last updated
- 29 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Longitudinal Functional Magnetic Resonance Imaging (fMRI) as a Brain Measure for Impulsivity in a Borderline Personality Disorder (BPD) Model
- ClinicalTrials.gov ID
- NCT02755181
- Acronym / sponsor ID
- 352.2067
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 28 Apr 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.
This study aims to use resting-state and task based functional Magnetic Resonance Imaging (fMRI) as a tool to evaluate trait characteristics of impulsivity in subjects with borderline personality disorder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPD | – | Behavioral: ExperimentalBorderline Personality Disorder as diagnosed by DSM-5 |
| normal volunteers | – | Behavioral: Experimentalnormal volunteers |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- BPD and normal volunteers
Key inclusion criteria (2 listed)
- Healthy Controls: Volunteers (age 18-50 yrs) in generally good Psychiatric and non-Psychiatric medical health
- Borderline Personality Disorder subjects: Research volunteers (age 18-50 yrs) who meet DSM-5 criteria for Borderline Personality Disorder
Key exclusion criteria (19 listed)
- Current medications which affect the central nervous system or vascular activity, such as anti-depressants, anxiolytics, or blood-pressure medications
- Positive urine drug screen for cocaine, opioids, amphetamine, and benzodiazepines
- Positive breathalyzer test for alcohol
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimentalwith functional imaging and behavioural measurements at baseline and 4 weeks | Behavioural | BPD, normal volunteers |
Primary outcome
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Affective Faces Task (AFT) fMRI response
Time frame: up to 5 weeks
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Monetary Incentive Delay (MID) fMRI task response
Time frame: up to 5 weeks
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for resting-state functional magnetic resonance imaging (fMRI) activity
Time frame: up to 5 weeks
Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/ No Go functional magnetic resonance imaging (fMRI) response
Time frame: up to 5 weeks
11 secondary outcomes
Change from baseline to 4 week follow-up visit for Eye Tracking
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) behavioral test
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 procedure behavioral test
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 paradigm behavioral test
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 Scale v.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 Profile of Mood States behavioral test
Time frame: 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 behavioral test
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, subscale for premeditation
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, subscale for perseverance
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, subscale for sensation seeking
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, subscale for urgency
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 29 Aug 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 and Borderline Personality Disorder, 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 2 inclusion and 19 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 29 Aug 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 Affective Faces Task (AFT) fMRI response (time frame: up to 5 weeks). The study lists 4 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 29 Aug 2018.