Overview

This trial is active, not recruiting.

Condition borderline personality disorder
Treatment acetaminophen
Phase phase 2
Sponsor Ohio State University
Collaborator National Center for Advancing Translational Science (NCATS)
Start date September 2013
End date December 2016
Trial size 30 participants
Trial identifier NCT02108990, 2012HO294, KL2RR025754-04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Acetaminophen 1000mg capsule orally three times a day
acetaminophen Tylenol
(Experimental)
500mg Acetaminophen orally three times a day
acetaminophen Tylenol

Primary Outcomes

Measure
Change from baseline in symptom reports on the PAI-BOR at week 6
time frame: Baseline, Week 6
Change from baseline in symptom severity on the Zanarini Rating Scale for Borderline Personality Disorder
time frame: Baseline, Week 6

Secondary Outcomes

Measure
Symptom Reports
time frame: Baseline, weeks, 1,2,3,4,5,6 and 8.
Daily Diary
time frame: Daily for week 0,1,2, and 3

Eligibility Criteria

Female participants from 18 years up to 50 years old.

Inclusion Criteria: - clinical diagnosis of borderline personality disorder - 18 years or older - if on psychiatric medication, must be on a stable dose - able to swallow tablets Exclusion Criteria: - 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.

Additional Information

Official title Acetaminophen and Social Pain in Borderline Personality Disorder
Principal investigator Baldwin M Way, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Ohio State University.