Completed

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

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What is being tested

Data Collection

Who is being recruted

Mental Disorders

+ Borderline Personality Disorder

+ Personality Disorders

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 2004
See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2004

Actual date on which the first participant was enrolled.

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

Official TitleEfficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder: A Randomized Double-Blind Comparison With Placebo 
NCT00088036
Principal SponsorEli Lilly and Company
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

450 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBorderline Personality DisorderPersonality Disorders

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: * 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Suspended

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

National City, United StatesSee the location
Suspended

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician

New Haven, United States
Suspended

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Indianapolis, United States
Suspended

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Jackson, United States
Completed15 Study Centers