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.

Condition	Treatment or Intervention	Phase
Borderline Personality Disorder	Drug: Olanzapine and Placebo	Phase III

Ages Eligible for Study:  15 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients must be of outpatient status at Visit 1 and through Visit 2.
• Patients must be 15 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.
• The symptom severity must be mild to moderate.
• Female patients of childbearing potential must test negative for pregnancy and must be using a medically accepted means of contraception throughout the course of 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• Have previously participated (have been randomized) or withdrawn from this study or any other Lilly sponsored study investigating olanzapine.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.

"There may be multiple sites in this clinical trial."      1-877-CTLILLY (1-877-285-4559) 

California
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", El Centro,  California,  United States; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Sherman Oaks,  California,  United States; Recruiting
Georgia
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Atlanta,  Georgia,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Marietta,  Georgia,  United States; Recruiting
Massachusetts
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Belmont,  Massachusetts,  United States; Recruiting
Minnesota
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Minneapolis,  Minnesota,  United States; Recruiting
Nevada
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", North Las Vegas,  Nevada,  United States; Recruiting
North Dakota
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bismarck,  North Dakota,  United States; Recruiting
Ohio
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Beachwood,  Ohio,  United States; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Cincinnati,  Ohio,  United States; Recruiting
Pennsylvania
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Media,  Pennsylvania,  United States; Recruiting
Virginia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Charlottesville,  Virginia,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Virginia Beach,  Virginia,  United States; Recruiting
Washington
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bellevue,  Washington,  United States; Recruiting
Belgium
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", LIEGE,  Belgium; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Brussels,  Belgium; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Kortenberg,  Belgium; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Kortrijk,  Belgium; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Lede,  Belgium; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Nieuwkerken-Waas,  Belgium; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Tielt,  Belgium; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Leper,  Belgium; Recruiting
France
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Mannheim,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bordeaux Cedex,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bully-les-Mines,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Colombes Cedex,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Dijon Cedex,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Le Kremlin-Bicetre,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Marseille Cedex 09,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Nimes Cedex 4,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Paris,  France; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Toulouse,  France; Recruiting
Germany
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", STRALSUND,  Germany; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Herpertz,  Germany; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Bonn,  Germany; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Aachen,  Germany; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Berlin,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Freiburg,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Lubeck,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Mannheim,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Rostock,  Germany; Recruiting
Norway
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Brattvag,  Norway; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Oslo,  Norway; Recruiting
Portugal
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Norway,  Portugal; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Coimbra,  Portugal; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Lisbon,  Portugal; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Porto,  Portugal; Recruiting
Spain
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Barcelona,  Spain; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Vizcaya,  Spain; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Madrid,  Spain; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Santander,  Spain; Recruiting
Sweden
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", Stockholm,  Sweden; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Cent at 1-877-285-4559) or speak with your personal physician.", SUNDSVALL,  Sweden; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Alvsjo,  Sweden; Recruiting
United Kingdom
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., London,  United Kingdom; Recruiting

Study ID Numbers:  6257
Record last reviewed:  March 2005
Last Updated:  March 8, 2005
Record first received:  September 14, 2004
ClinicalTrials.gov Identifier:  NCT00091650
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08