Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder

What is being tested

Olanzapine

Drug

Who is being recruted

Borderline Personality Disorder

From 18 to 65 Years

+10 Eligibility Criteria

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: July 24, 2006

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2004Actual 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

Principal SponsorEli Lilly and Company

Last updated: July 24, 2006

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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

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

Conditions

Criteria

Any sexBiological sex of participants that are eligible to enroll.

From 18 to 65 YearsRange of ages for which participants are eligible to join.

Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Borderline Personality Disorder

Criteria

5 inclusion criteria required to participate

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

Show More Criteria

5 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

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

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 physicianNational 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 physicianNew 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 physicianIndianapolis, 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 physicianJackson, United States

Completed15 Study Centers

Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder

Olanzapine

Borderline Personality Disorder

Treatment Study

Summary

Protocol

Randomized Allocation

Parallel Assignment

Double-Blind Study

Eligibility

Conditions

Criteria

Study Plan

Study Objectives

To assess the efficacy of olanzapine therapy (5.0-10.0 mg/day) compared with placebo in patients with BPD,as defined by DSM-IV-TR criteria,

in improving overall symptomatology as measured by the last observation carried forward (LOCF) mean change from baseline to endpoint in the ZAN-BPD total score for up to 12 weeks of double-blind treatment.

To assess the efficacy of olanzapine 2.5 mg/day compared with placebo in patients with BPD, as defined by DSM-IV-TR criteria

in improving overall symptomatology as measured by last observation carried forward (LOCF) mean change from baseline to endpoint in the ZAN-BPD total score for up to 12 weeks of double-blind treatment

to evaluate the level of functioning as measured by LOCF mean change from baseline to endpoint on the Sheehan Disability Scale (Work, Social Life,and Family Life/Home Responsibilities)total score

and individual scores(Work, Social Life,Family Life/Home Responsibilities, Days Lost, and Days Under Productive)

to assess the reduction of aggression, suicidality, and irritability as measured by the LOCF mean change from baseline to endpoint in the rating of the Overt Aggression Scale-Modified (OAS-M) total score

to assess the reduction of self-mutilation determined by the mean frequency of self-mutilation attempts as captured on the Lifetime Self-Destructiveness scale (LSDS), which will measure both frequency and nature of attempts

The frequency of self-mutilation for each patient will be calculated as the number of self-mutilations divided by the patient's total number of study drug exposure

(Self-mutilation is defined as deliberate physical self harm without the intent to commit suicide)

to assess the reduction of suicide attempts as determined by the mean frequency of suicide attempts.

The frequency of suicide attempts for each patient will be calculated as the number of suicide attempts divided by the patient's total number of days of study drug exposure

to assess the treatment of the core domains of BPD as assessed by LOCF mean change from baseline to endpoint in each of the four ZAN-BPD domain scores (cognitive disturbances,disturbed relationships,affective disturbances,and impulsivity)

to assess the following symptom domains (paranoid ideation, psychoticism, anxiety, depression, anger/hostility, interpersonal sensitivity, phobic anxiety, obsessive-compulsive, and somatization)on the Global Severity Index of the SCL-90-R

as determined by the LOCF mean change from baseline to endpoint

to evaluate the rate of response, time in response, and time to response. Levels of response are defined as a 30% and 50% reduction in the ZAN-BPD total score from baseline (Visit 2)

to assess the treatment of depressive mood symptoms as measured by LOCF mean change from baseline to endpoint in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)

to assess the resource utilization by frequency divided by the patient's total number of days of study drug exposure for days hospitalized for physical and psychological reasons,number of hospital admissions

or medical visits(emergency department, general and special care physicians, and other mental health care professionals

to evaluate the level of functioning in patients as measured by LOCF mean change from baseline to endpoint on the GAF

to assess the safety as measured by treatment-emergency adverse events (TEAE), change in vital signs and laboratory analytes, electrocardiograms and severity of any extrapyramidal symptoms (EPS)

The Simpson Angus Scale, Abnormal Involuntary Movement Scale and Barnes Akathisia Scale will be used to measure EPS

The objectives of Study Period III (Open Label Extension Period are:

to assess the longer term safety of olanzapine for up to 12 additional weeks of therapy

as measured by TEAE, change in vital signs and laboratory analytes, ECG and severity of EPS.

to explore the efficacy of continued olanzapine treatment for up to 12 additional weeks of therapy

as measured by the ZAN-BPD total score, MADRS, Sheehan Disability Scale and LSDS

to assess resource utilization by frequency of divided by the patient's total number of days of study drug exposure for

days hospitalized for physical and psychological reasons, number of hospital admissions

or medical visits (emergency department, general and special care physicians or other mental health care professionals

Study Centers

This study has 15 locations