Brief Summary

The goals of this study are to determine: the safety of olanzapine and any side effects that might be associated with it, how olanzapine compares to placebo, whether olanzapine can help patients with symptoms of Borderline Personality Disorder (BPD), and how much olanzapine should be given to patients.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

300

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Mar 2004

Geographic Reach

9 countries

39 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

March 1, 2004

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2004

Completed

13 days until next milestone

First Posted

Study publicly available on registry

September 27, 2004

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed

Last Updated

July 24, 2006

Status Verified

July 1, 2006

First QC Date

September 14, 2004

Last Update Submit

July 21, 2006

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (4)

To assess the efficacy of olanzapine therapy (2.5 to 20.0 mg/day) compared with placebo in patients greater than or
equal to 18 years of age, with a diagnosis of BPD as defined by DSM-IV-TR criteria, in improving overall symptomatology as measured by the mean last observation
carried forward (LOCF) change in the ZAN-BPD
total score in up to 12 weeks of double-blind treatment.

Secondary Outcomes (2)

To assess the efficacy effect of olanzapine therapy (2.5 to 20.0 mg/day) compared with placebo in patients greater than or equal to 15 years of age and less than 18 years of age
with BPD, as defined by DSM-IV-TR criteria, in improving overall symptomatology as measured by the mean LOCF change in the ZAN-BPD total score for up to 12 weeks of double-blind treatment.

Interventions

OlanzapineDRUG

placeboDRUG

Eligibility Criteria

Age15 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Patients must be of outpatient status at visit 1 and through visit 2.
Patients must be 15 to 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.
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 a medically accepted means of contraception throughout the course of the study.

You may not qualify if:

Patients must not be 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.
Patients must not have previously participated (have been randomized) or withdrawn from this study or any other Lilly sponsored study investigating olanzapine.
Patients must not have had previous treatment with olanzapine unless, in the opinion of the investigator, the patients' 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 must not be pregnant or nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (39)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Atlanta, Georgia, United States

Location

Marietta, Georgia, United States

Location

Minneapolis, Minnesota, United States

Location

Las Vegas, Nevada, United States

Location

Bismarck, North Dakota, United States

Location

Media, Pennsylvania, United States

Location

Charlottesville, Virginia, United States

Location

Virginia Beach, Virginia, United States

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Bellevue, Washington, United States

Location

Brussels, Belgium

Location

Kortenberg, Belgium

Location

Liège, Belgium

Location

Nieuwkerken-Waas, Belgium

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Tielt, Belgium

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Bordeaux, France

Location

Bully-les-Mines, France

Location

Colombes, France

Location

Dijon, France

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Le Kremlin-Bicêtre, France

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Marseille, France

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Nîmes, France

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Paris, France

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Sceaux, France

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Toulouse, France

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Aachen, Germany

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Berlin, Germany

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Freiburg im Breisgau, Germany

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Mannheim, Germany

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Rostock, Germany

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Stralsund, Germany

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Brattvåg, Norway

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Oslo, Norway

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Lisbon, Portugal

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Porto, Portugal

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Barcelona, Spain

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Madrid, Spain

Location

Älvsjö, Sweden

Location

Stockholm, Sweden

Location

London, United Kingdom

Location

Related Publications (4)

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.
PMID: 36375174DERIVED
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.
PMID: 22967772DERIVED
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.
PMID: 21095016DERIVED
Schulz SC, Zanarini MC, Bateman A, Bohus M, Detke HC, Trzaskoma Q, Tanaka Y, Lin D, Deberdt W, Corya S. Olanzapine for the treatment of borderline personality disorder: variable dose 12-week randomised double-blind placebo-controlled study. Br J Psychiatry. 2008 Dec;193(6):485-92. doi: 10.1192/bjp.bp.107.037903.
PMID: 19043153DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 14, 2004

First Posted

September 27, 2004

Study Start

March 1, 2004

Study Completion

November 1, 2005

Last Updated

July 24, 2006

Record last verified: 2006-07

Locations

FR(10)ES(2)US(9)PT(2)DE(6)BE(5)NO(2)SE(2)GB(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (39)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations