Olanzapine in Patients With Borderline Personality Disorder
The goals of this study are to determine: the safety of olanzapine and any side effects that might be associated with it, how olanzapine compares to placebo, whether olanzapine can help patients with symptoms of Borderline Personality Disorder (BPD), and how much olanzapine should be given to patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder: A Randomized Flexible Dose Double-Blind Comparison With Placebo|
- To assess the efficacy of olanzapine therapy (2.5 to 20.0 mg/day) compared with placebo in patients greater than or
- equal to 18 years of age, with a diagnosis of BPD as defined by DSM-IV-TR criteria, in improving overall symptomatology as measured by the mean last observation
- carried forward (LOCF) change in the ZAN-BPD
- total score in up to 12 weeks of double-blind treatment.
- To assess the efficacy effect of olanzapine therapy (2.5 to 20.0 mg/day) compared with placebo in patients greater than or equal to 15 years of age and less than 18 years of age
- with BPD, as defined by DSM-IV-TR criteria, in improving overall symptomatology as measured by the mean LOCF change in the ZAN-BPD total score for up to 12 weeks of double-blind treatment.
|Study Start Date:||March 2004|
|Estimated Study Completion Date:||November 2005|
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|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|