None listed
Conditions
Interventions
• At Visit 2, patients will start taking olanzapine 2.5 mg / day.
• At Visit 3 the dose of olanzapine will be increased to 5.0 mg / day.
• Starting at Visit 4, the dose can be maintained at 5.0 mg / day or can be adjusted to 7.5 or 10.0 mg / day
Group name:placebo Type of group
Olanzapine placebo will be administered
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion 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 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
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parent, child, or sibling, whether biological or legally adopted Have previously participated (have been randomized) or withdrawn from this study or any other Lilly sponsored study investigating olanzapine.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Total Score ZAN-BPD Measure:Efficacy of olanzapine therapy (5.0 to 10.0 mg / day) compared with placebo in patients with BPD Timepoints:weekly | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Total Score ZAN-BPD Measure:eficacia de la terapia con olanzapina 2.5 mg/dia comparada con placebo en pacientes con BPD, en mejorar la sintomatologia general medida en el puntaje total de ZANBPD hasta por 12 semanas de tratamiento a doble ciego. Timepoints:weekly | — |
Countries
Argentina, Peru, Poland, Romania, Turkey, United States
Outcome results
None listed