Status:
COMPLETED
Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder
Lead Sponsor:
Mood and Anxiety Research, Inc
Conditions:
Borderline Personality Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.
Detailed Description
Borderline Personality Disorder (BPD) is a chronic disorder occurring in 2-3% of the population. BPD is accompanied by high levels of co-existing psychiatric and physical disorders. One key predictor ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01912391
Start Date
October 1 2012
End Date
March 1 2015
Last Update
October 8 2015
Active Locations (1)
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1
Mood and Anxiety Research, Inc
Fresno, California, United States, 93720