NCT02755181

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 22, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

April 8, 2016

Last Update Submit

August 28, 2018

Conditions

Impulse Control DisordersBorderline Personality Disorder

Outcome Measures

Primary Outcomes (4)

  • Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Affective Faces Task (AFT) fMRI response

    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

    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

    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

    up to 5 weeks

Secondary Outcomes (11)

  • Change from baseline to 4 week follow-up visit for Eye Tracking

    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

    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

    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

    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)

    up to 5 weeks

  • +6 more secondary outcomes

Study Arms (2)

BPD

Borderline Personality Disorder as diagnosed by DSM-5

Behavioral: Experimental

normal volunteers

normal volunteers

Behavioral: Experimental

Interventions

ExperimentalBEHAVIORAL

with functional imaging and behavioural measurements at baseline and 4 weeks

BPDnormal volunteers

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

BPD and normal volunteers

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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:
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Disruptive, Impulse Control, and Conduct DisordersBorderline Personality Disorder

Condition Hierarchy (Ancestors)

Mental DisordersPersonality Disorders

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 28, 2016

Study Start

July 22, 2016

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

US(1)