Borderline Personality DisorderPhase 3NCT00091650
Olanzapine in Patients With Borderline Personality Disorder
A Phase 3 study testing Olanzapine in people with Borderline Personality Disorder, run by Eli Lilly and Company at 39 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 39 sitesin 9 countries
- Study dates
- Mar 2004to Nov 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
39 sites in 9 countries.
39 sites in 9 countries
France10 sites
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
Bordeaux
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Bully-les-Mines
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Colombes
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Dijon
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Le Kremlin-Bicêtre
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Marseille
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Nîmes
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Paris
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Sceaux
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Toulouse
United States9 sites
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
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Bellevue, Washington
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Bismarck, North Dakota
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Charlottesville, Virginia
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Las Vegas, Nevada
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Marietta, Georgia
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Media, Pennsylvania
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Minneapolis, Minnesota
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Virginia Beach, Virginia
Germany6 sites
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Aachen
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Berlin
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Freiburg im Breisgau
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Mannheim
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Rostock
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Stralsund
Belgium5 sites
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Brussels
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Kortenberg
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Liège
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Nieuwkerken-Waas
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Tielt
Norway2 sites
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Brattvåg
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Oslo
Portugal2 sites
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Lisbon
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Porto
Spain2 sites
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
Barcelona
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Madrid
Sweden2 sites
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
Älvsjö
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Stockholm
United Kingdom1 site
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London
About this study
Official title: Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder: A Randomized Flexible Dose Double-Blind Comparison With Placebo
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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Olanzapine, placebo
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2004 (estimated)
- Study startMar 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091650
- Sponsor's protocol ID
- 6257
- Other IDs
- F1D-MC-HGKL
- Status last verified
- Jul 2006
- First submitted
- 14 Sep 2004
- Last updated
- 24 Jul 2006
- Results posted
- No
Publications
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.
PubMed 36375174Houston 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.
PubMed 22967772Houston 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.
PubMed 21095016Schulz 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.
PubMed 19043153
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder: A Randomized Flexible Dose Double-Blind Comparison With Placebo
- ClinicalTrials.gov ID
- NCT00091650
- Acronym / sponsor ID
- 6257
- Conditions
- Borderline Personality Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Nov 2005
- First posted
- 27 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olanzapine | Drug | – |
| placebo | Drug | – |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2006.
- Derived from this study: PubMed 36375174Stoffers-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.
- Derived from this study: PubMed 22967772Houston 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.
- Derived from this study: PubMed 21095016Houston 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.
- Derived from this study: PubMed 19043153Schulz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
39 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine in people with Borderline Personality Disorder, run by Eli Lilly and Company at 39 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in France, United States, Germany, Belgium, Norway and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of olanzapine therapy (2.5 to 20.0 mg/day) compared with placebo in patients greater than or. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00091650, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2006.