Olanzapine in Patients With Borderline Personality Disorder
NCT ID: NCT00091650
Last Updated: 2006-07-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
300 participants
Study Classification
INTERVENTIONAL
Study Start Date
2004-03-31
Study Completion Date
2005-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Borderline Personality Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Interventions
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Olanzapine
Intervention Type
DRUG
placebo
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
Minimum Eligible Age
15 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Site Status
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Marietta, Georgia, United States
Site Status
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Minneapolis, Minnesota, United States
Site Status
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Las Vegas, Nevada, United States
Site Status
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Bismarck, North Dakota, United States
Site Status
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Media, Pennsylvania, United States
Site Status
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Charlottesville, Virginia, United States
Site Status
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Virginia Beach, Virginia, United States
Site Status
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Bellevue, Washington, United States
Site Status
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Brussels, , Belgium
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Kortenberg, , Belgium
Site Status
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Liège, , Belgium
Site Status
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Nieuwkerken-Waas, , Belgium
Site Status
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Tielt, , Belgium
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Bordeaux, , France
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Bully-les-Mines, , France
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Colombes, , France
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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
Site Status
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Mannheim, , Germany
Site Status
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Rostock, , Germany
Site Status
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Stralsund, , Germany
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Brattvåg, , Norway
Site Status
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Oslo, , Norway
Site Status
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Lisbon, , Portugal
Site Status
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Porto, , Portugal
Site Status
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Barcelona, , Spain
Site Status
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Madrid, , Spain
Site Status
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Älvsjö, , Sweden
Site Status
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Stockholm, , Sweden
Site Status
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London, , United Kingdom
Site Status
Countries
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United States
Belgium
France
Germany
Norway
Portugal
Spain
Sweden
United Kingdom
References
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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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
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F1D-MC-HGKL
Identifier Type: -
Identifier Source: secondary_id
6257
Identifier Type: -
Identifier Source: org_study_id