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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02108990
Other study ID # 2012HO294
Secondary ID KL2RR025754-04
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2013
Est. completion date June 30, 2014

Study information

Verified date May 2024
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date June 30, 2014
Est. primary completion date June 30, 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Acetaminophen


Locations

Country Name City State
United States The Ohio State University Columbus Ohio

Sponsors (3)

Lead Sponsor Collaborator
Ohio State University National Center for Advancing Translational Sciences (NCATS), National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in symptom reports on the PAI-BOR at week 6 Symptom reports on the PAI-BOR. Baseline, Week 6
Primary 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 Symptom Reports Each week participants will be emailed a link to complete that will have three surveys.
The Beck Depression Inventory
The Beck Anxiety Inventory
The Inventory of Interpersonal Problems (Aggression and Interpersonal Sensitivity Subscales).
This weekly survey report will also be sent to the participants once after the completion of pharmacotherapy (at the two weeks post cessation treatment).
Baseline, weeks, 1,2,3,4,5,6 and 8.
Secondary Daily Diary The importance of these measures will be to assess how rejected, aggressive, and social participants have been in order to determine if acetaminophen affects these proclivities. Participants will report on: hurt feelings, rejection, affect, aggressive feelings, impulsive behaviors, alcohol use, sleep, social interactions, perceived stress, self-esteem Daily for week 0,1,2, and 3
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