Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder

Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder: A Randomized Double-Blind Comparison With Placebo

The purpose of the protocol is to evaluate the efficacy and safety of olanzapine compared with placebo in patients with Borderline Personality Disorder (BPD).

Inclusion Criteria:

• Patients must be of outpatient status at Visit 1 and through Visit 2
• Patients must be 18 through 65 years of age at Visit 1
• Patients must meet all of the DSM-IV-TR General Diagnostic Criteria for a Personality Disorder AND Patients must meet DSM-IV-TR diagnostic criteria for BPD as determined by the DIPD-IV, confirmed by a psychiatrist with training in the evaluation and assessment of BPD.
• The symptom severity as assessed by the total score of the ZAN-BPD, confirmed by a psychiatrist with training in the evaluation and assessment of BPD, must be greater than or equal to 9 at Visit 2.
• Female patients of childbearing potential must test negative for pregnancy and must be using medically accepted means of contraception throughout the study. Use of any oral or injectable contraception must be initiated prior to Visit 2.

Exclusion Criteria:

• Investigators, study site personnel directly affiliated with the study, or immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
• Persons employed by Lilly (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
• Have previously participated (have been randomized) or withdrawn from this study or any other Lilly sponsored study investigating olanzapine.
• Have had previous treatment with olanzapine unless, in the opinion of the investigator, the patient's previous treatment was inadequate in dose or duration to provide an accurate assessment of the therapy, or the effect of olanzapine was confounded by concomitant medication.
• Female patients who are either pregnant or nursing.