Back to resultsEfficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder
Primary Purpose
Borderline Personality Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder
Eligibility 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parent, child, or sibling, whether biological or legally adopted Have previously participated (have been randomized) or withdrawn from this study or any other Lilly sponsored study investigating olanzapine.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.
Sites / Locations
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00088036
Brief Title
Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder
Official Title
Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder: A Randomized Double-Blind Comparison With Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
The purpose of the protocol is to evaluate the efficacy and safety of olanzapine compared with placebo in patients with Borderline Personality Disorder (BPD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
450 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Primary Outcome Measure Information:
Title
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,
Title
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.
Secondary Outcome Measure Information:
Title
To assess the efficacy of olanzapine 2.5 mg/day compared with placebo in patients with BPD, as defined by DSM-IV-TR criteria
Title
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
Title
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
Title
and individual scores(Work, Social Life,Family Life/Home Responsibilities, Days Lost, and Days Under Productive)
Title
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
Title
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
Title
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
Title
(Self-mutilation is defined as deliberate physical self harm without the intent to commit suicide)
Title
to assess the reduction of suicide attempts as determined by the mean frequency of suicide attempts.
Title
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
Title
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)
Title
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
Title
as determined by the LOCF mean change from baseline to endpoint
Title
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)
Title
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)
Title
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
Title
or medical visits(emergency department, general and special care physicians, and other mental health care professionals
Title
to evaluate the level of functioning in patients as measured by LOCF mean change from baseline to endpoint on the GAF
Title
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)
Title
The Simpson Angus Scale, Abnormal Involuntary Movement Scale and Barnes Akathisia Scale will be used to measure EPS
Title
The objectives of Study Period III (Open Label Extension Period are:
Title
to assess the longer term safety of olanzapine for up to 12 additional weeks of therapy
Title
as measured by TEAE, change in vital signs and laboratory analytes, ECG and severity of EPS.
Title
to explore the efficacy of continued olanzapine treatment for up to 12 additional weeks of therapy
Title
as measured by the ZAN-BPD total score, MADRS, Sheehan Disability Scale and LSDS
Title
to assess resource utilization by frequency of divided by the patient's total number of days of study drug exposure for
Title
days hospitalized for physical and psychological reasons, number of hospital admissions
Title
or medical visits (emergency department, general and special care physicians or other mental health care professionals
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
City
National City
State/Province
California
Country
United States
Facility Name
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
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
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
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
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
City
Jackson
State/Province
Mississippi
Country
United States
Facility Name
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
City
Bronx
State/Province
New York
Country
United States
Facility Name
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
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
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
City
Houston
State/Province
Texas
Country
United States
Facility Name
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
City
Capital Federal
State/Province
Buenos Aires
Country
Argentina
Facility Name
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
City
La Plata
State/Province
Buenos Aires
Country
Argentina
Facility Name
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
City
Villa Alberdi
State/Province
Cordoba
Country
Argentina
Facility Name
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
City
Buenos Aires
Country
Argentina
Facility Name
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
City
Choroszcz
Country
Poland
Facility Name
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
City
Torun
Country
Poland
Facility Name
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
City
Bucuresti
State/Province
Sector 4
Country
Romania
Facility Name
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
City
Istanbul
State/Province
Capa
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
36375174
Citation
Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
Results Reference
derived
PubMed Identifier
22967772
Citation
Houston JP, Kohler J, Bishop JR, Ellingrod VL, Ostbye KM, Zhao F, Conley RR, Poole Hoffmann V, Fijal BA. Pharmacogenomic associations with weight gain in olanzapine treatment of patients without schizophrenia. J Clin Psychiatry. 2012 Aug;73(8):1077-86. doi: 10.4088/JCP.11m06916.
Results Reference
derived
PubMed Identifier
21535995
Citation
Zanarini MC, Schulz SC, Detke HC, Tanaka Y, Zhao F, Lin D, Deberdt W, Kryzhanovskaya L, Corya S. A dose comparison of olanzapine for the treatment of borderline personality disorder: a 12-week randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2011 Oct;72(10):1353-62. doi: 10.4088/JCP.08m04138yel.
Results Reference
derived
PubMed Identifier
21095016
Citation
Houston J, Dharia S, Bishop JR, Ellingrod VL, Fijal B, Jacobson JG, Hoffmann VP. Association of DRD2 and ANKK1 polymorphisms with prolactin increase in olanzapine-treated women. Psychiatry Res. 2011 May 15;187(1-2):74-9. doi: 10.1016/j.psychres.2010.10.020. Epub 2010 Nov 20.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder
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