Overview
Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder
Status:
Completed
Completed
Trial end date:
2015-03-01
2015-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.Phase:
Phase 3Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Mood and Anxiety Research, IncTreatments:
Selegiline
Criteria
Inclusion Criteria:- 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 Criteria:
- 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.