Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder
A Phase III Randomized Double-blind, 12 Week, Placebo Controlled Trial of Transdermal Selegiline in Borderline Personality Disorder (BPD) to Evaluate Efficacy and Safety
2 other identifiers
interventional
30
1 country
1
Brief Summary
Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 16, 2013
CompletedFirst Posted
Study publicly available on registry
July 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedOctober 8, 2015
October 1, 2015
2.4 years
July 16, 2013
October 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale
The study subject will complete the SCL 90-R questionnaire at each visit on arrival at the office prior to meeting with the research staff. This will serve as the primary efficacy measure of outcome for the study. This instrument has been utilized in clinical trials since the early 1960s, and has a good ability to measure overall levels of psychological and physical functioning in this patient group.
Weeks 1-12
Secondary Outcomes (4)
Secondary Efficacy Measurement: Change in Hamilton Depression Inventory 17 Questions (HAM-D)
Weeks 1 - 12
Clinical Global Impression of Change- Clinician (CGIc)
Weeks 3-12
Clinical Global Impression Change- Patient (CGIp)
Weeks 3 -12
Sheehan Disability Scale (SDS)
Weeks 1, 4, 12
Other Outcomes (1)
Clinical and Laboratory Measurements for Safety: Change in Columbia Suicide Severity Rating Scale (CSSRS); Adverse Events; Vitals Signs; Body Weight; Laboratory Values; Blood Pressure; Study Drug Compliance; Concomitant Medication Compliance
Treatment Phase (1-12 weeks)
Study Arms (2)
Selegiline
EXPERIMENTALTransdermal Selegiline 12 mg patch Apply (1) patch daily
Placebo (for Selegiline)
PLACEBO COMPARATORTransdermal Placebo patch Apply (1) patch daily
Interventions
The Study Drug known as either selegiline 12 mg patch or matching placebo patch will be administered daily beginning at Visit 2 for the duration of 12 weeks.
Transdermal Placebo patch manufactured to mimic Transdermal Selegiline 12 mg. patch
Eligibility Criteria
You may qualify if:
- Subject has primary diagnosis of Borderline Personality Disorder(BPD).
- Subject has Symptomatology of BPD for at least 1 year.
- Subject understands the study procedures and voluntarily agree to participate.
- Subject is able to read, understand and complete questionnaires.
- Subject agrees to use (2)acceptable forms of contraception throughout the study.
- Patient must have a screening SCL 90-R score of \> 120 (range 0-360).
You may not qualify if:
- Subject is not pregnant or breast feeding.
- Subject is unlikely to adhere to the study procedures and restrictions.
- Patient has failed treatment due to lack of efficacy of monoamine oxidase inhibitor(MAOI) medication.
- Patient anticipates need for surgery during the study.
- Patient has another predominant personality disorder other than BPD.
- Subject has an active history of substance abuse or dependence, e.g.,Positive Drug screen
- Subject has other health issues which could interfere with study interpretation.
- Subject reports recent suicide attempts or homicide attempts in the past 3 months.
- Subject must be substance abuse or dependence clean for (1) year.
- Subject has a history of a primary malignancy \< 5 yrs.
- Subject has a medical condition(s)that are excluded, per Protocol, or are unstable.
- Subject has abnormal screening laboratory values, per Protocol, or other clinically significant, unexplained laboratory abnormality.
- Subject is currently participating or has participated in a study within 30 days.
- Patient has donated blood products or has had phlebotomy of \> 300 ml within 8 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mood and Anxiety Research, Inc
Fresno, California, 93720, United States
Related Publications (1)
Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
PMID: 36375174DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul J Markovitz, MD, PhD
Mood and Anxiety Research, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2013
First Posted
July 31, 2013
Study Start
October 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
October 8, 2015
Record last verified: 2015-10