Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder (NCT01912391) | Clinical Trial Compass
CompletedPhase 3
Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder
United States30 participantsStarted 2012-10
Plain-language summary
Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 stud…
What they're measuring
1
Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale