Overview

Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder

Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
Summary
Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mood and Anxiety Research, Inc
Treatments:
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.