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

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

Ages Eligible for Study:  18 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 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.
• The symptom severity must be mild to moderate at Visit 2.
• Female patients of childbearing potential must test negative for pregnancy and must be using 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• Have previously participated (have been randomized) or withdrawn from this study or any other Lilly sponsored study investigating olanzapine.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 Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician, Chula Vista,  California,  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., National City,  California,  United States; Recruiting
Connecticut
      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, Farmington,  Connecticut,  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, New Haven,  Connecticut,  United States; Recruiting
Florida
      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, Fort Meyers,  Florida,  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, North Miami,  Florida,  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., Sarasota,  Florida,  United States; Recruiting
Georgia
      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
Hawaii
      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, Honolulu,  Hawaii,  United States; Recruiting
Illinois
      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, Chicago,  Illinois,  United States; Recruiting
Indiana
      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, Indianapolis,  Indiana,  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, Terre Haute,  Indiana,  United States; Recruiting
Iowa
      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., Iowa City,  Iowa,  United States; Recruiting
Kansas
      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, Topeka,  Kansas,  United States; Recruiting
Maryland
      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, Glen Burnie,  Maryland,  United States; Recruiting
Massachusetts
      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, Belmont,  Massachusetts,  United States; Recruiting
Minnesota
      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, Minneapolis,  Minnesota,  United States; Recruiting
Mississippi
      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, Jackson,  Mississippi,  United States; Recruiting
New Jersey
      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, Cherry Hill,  New Jersey,  United States; Recruiting
New York
      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, Bronx,  New York,  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, Olean,  New York,  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, Staten Island,  New York,  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., Staten Island,  New York,  United States; Recruiting
Oklahoma
      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, Oklahoma City,  Oklahoma,  United States; Recruiting
Rhode Island
      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, Providence,  Rhode Island,  United States; Recruiting
South Carolina
      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, Charleston,  South Carolina,  United States; Recruiting
Tennessee
      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, Memphis,  Tennessee,  United States; Recruiting
Texas
      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, Austin,  Texas,  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, Houston,  Texas,  United States; Recruiting
Utah
      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, Salt Lake City,  Utah,  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., Richmond,  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
      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, Kirkland,  Washington,  United States; Recruiting
Argentina
      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., Buenos Aires,  Argentina; Recruiting
Argentina, Buenos Aires
      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., Capital Federal,  Buenos Aires,  Argentina; 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., La Plata,  Buenos Aires,  Argentina; Recruiting
Argentina, Cordoba
      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., Villa Alberdi,  Cordoba,  Argentina; Recruiting
Italy
      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., Pavai,  Italy; 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., Roma,  Italy; 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., Fano,  Italy; 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., Parma,  Italy; Recruiting
Poland
      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., Choroszcz,  Poland; 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., Torun,  Poland; Recruiting
Romania
      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., Iasi,  Romania; 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., Timisoara,  Romania; Recruiting
Romania, Sector 4
      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., Bucuresti,  Sector 4,  Romania; Recruiting
Turkey, Capa
      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., Istanbul,  Capa,  Turkey; Recruiting

Study ID Numbers:  6253; 28,705
Record last reviewed:  March 2005
Last Updated:  March 8, 2005
Record first received:  July 19, 2004
ClinicalTrials.gov Identifier:  NCT00088036
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08