NCT02108990

Brief Summary

Recent research has identified heightened sensitivity to social rejection as a core feature of BPD. Rejection sensitivity can trigger the aggressive, impulsive, and self-injurious behaviors characteristic of the disorder. Therefore targeting therapy towards the reduction of rejection sensitivity may improve the low rates of effectiveness of current pharmacological and behavioral therapies. Therefore, this proposal tests a theoretically-based pharmacological approach that specifically targets the heightened sensitivity to rejection experienced by BPD patients. In prior research with normal controls, it was shown that chronic treatment with the physical pain-killer acetaminophen (e.g. Tylenol) reduced both neural responses to social rejection (using fMRI) as well as self-reported feelings of rejection in a daily diary study. It is the aim of this research project to determine if the over-the-counter analgesic, acetaminophen (active ingredient in Tylenol), can reduce symptoms and behaviors in BPD patients. The goal of this proposal is to use an open-label design to determine if acetaminophen improves symptoms in BPD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2014

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

April 7, 2014

Last Update Submit

May 31, 2024

Conditions

Borderline Personality Disorder

Keywords

borderline personality disorderrejectionsocial pain

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in symptom reports on the PAI-BOR at week 6

    Symptom reports on the PAI-BOR.

    Baseline, Week 6

  • Change from baseline in symptom severity on the Zanarini Rating Scale for Borderline Personality Disorder

    Zanarini Rating Scale for Borderline Personality Disorder

    Baseline, Week 6

Secondary Outcomes (2)

  • Symptom Reports

    Baseline, weeks, 1,2,3,4,5,6 and 8.

  • Daily Diary

    Daily for week 0,1,2, and 3

Study Arms (1)

Acetaminophen 1000mg

EXPERIMENTAL

Acetaminophen 1000mg capsule orally three times a day

Drug: Acetaminophen

Interventions

AcetaminophenDRUG
Also known as: Tylenol
Acetaminophen 1000mg

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • clinical diagnosis of borderline personality disorder
  • years or older
  • if on psychiatric medication, must be on a stable dose
  • able to swallow tablets

You may not qualify if:

  • current, primary substance abuse, particularly alcoholism
  • current eating disorder
  • history or current psychotic disorder
  • suicidal ideation or behavior requiring imminent inpatient treatment
  • pregnancy
  • Participants whose medication has not been stable for more than 4 weeks
  • Impaired liver function (\> 1.25x the upper limit of the reference range)
  • Conditions that can affect immune system functioning.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Dewall CN, Macdonald G, Webster GD, Masten CL, Baumeister RF, Powell C, Combs D, Schurtz DR, Stillman TF, Tice DM, Eisenberger NI. Acetaminophen reduces social pain: behavioral and neural evidence. Psychol Sci. 2010 Jul;21(7):931-7. doi: 10.1177/0956797610374741. Epub 2010 Jun 14.

    PMID: 20548058BACKGROUND

MeSH Terms

Conditions

Borderline Personality DisorderRejection, Psychology

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Baldwin M Way, Ph.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

  • Jennifer S. Cheavens, Ph.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 9, 2014

Study Start

September 1, 2013

Primary Completion

June 30, 2014

Study Completion

June 30, 2014

Last Updated

June 4, 2024

Record last verified: 2024-05

Locations

US(1)