Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00088036
• Other study ID #: 6253
• Secondary ID: F1D-MC-HGKK
• Status: Completed
• Phase: Phase 3
• First received: July 19, 2004
• Last updated: July 21, 2006
• Start date: February 2004
• Est. completion date: January 2006

Study information

• Verified date: July 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Drug:
• Olanzapine

Locations

Country	Name	City	State
Argentina	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	Buenos Aires
Argentina	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	Capital Federal	Buenos Aires
Argentina	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	La Plata	Buenos Aires
Argentina	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	Villa Alberdi	Cordoba
Poland	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	Choroszcz
Poland	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	Torun
Romania	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	Bucuresti	Sector 4
Turkey	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	Istanbul	Capa
United States	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	Bronx	New York
United States	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	Houston	Texas
United States	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	Indiana
United States	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	Mississippi
United States	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	Memphis	Tennessee
United States	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	California
United States	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	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Poland,  Romania,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,
Primary	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	To assess the efficacy of olanzapine 2.5 mg/day compared with placebo in patients with BPD, as defined by DSM-IV-TR criteria
Secondary	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
Secondary	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
Secondary	and individual scores(Work, Social Life,Family Life/Home Responsibilities, Days Lost, and Days Under Productive)
Secondary	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
Secondary	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
Secondary	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
Secondary	(Self-mutilation is defined as deliberate physical self harm without the intent to commit suicide)
Secondary	to assess the reduction of suicide attempts as determined by the mean frequency of suicide attempts.
Secondary	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
Secondary	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)
Secondary	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
Secondary	as determined by the LOCF mean change from baseline to endpoint
Secondary	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)
Secondary	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)
Secondary	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
Secondary	or medical visits(emergency department, general and special care physicians, and other mental health care professionals
Secondary	to evaluate the level of functioning in patients as measured by LOCF mean change from baseline to endpoint on the GAF
Secondary	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)
Secondary	The Simpson Angus Scale, Abnormal Involuntary Movement Scale and Barnes Akathisia Scale will be used to measure EPS
Secondary	The objectives of Study Period III (Open Label Extension Period are:
Secondary	to assess the longer term safety of olanzapine for up to 12 additional weeks of therapy
Secondary	as measured by TEAE, change in vital signs and laboratory analytes, ECG and severity of EPS.
Secondary	to explore the efficacy of continued olanzapine treatment for up to 12 additional weeks of therapy
Secondary	as measured by the ZAN-BPD total score, MADRS, Sheehan Disability Scale and LSDS
Secondary	to assess resource utilization by frequency of divided by the patient's total number of days of study drug exposure for
Secondary	days hospitalized for physical and psychological reasons, number of hospital admissions
Secondary	or medical visits (emergency department, general and special care physicians or other mental health care professionals