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OpenTrials
Completed

NCT Number: NCT00091650

Olanzapine in Patients With Borderline Personality Disorder

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.

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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Olanzapine

Drug

Placebo

Drug

Primary outcomes

  1. To assess the efficacy of olanzapine therapy (2.5 to 20.0 mg/day) compared with placebo in patients greater than or

  2. 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

  3. carried forward (LOCF) change in the ZAN-BPD

  4. total score in up to 12 weeks of double-blind treatment.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 27, 2004
Registry last updated
Jul 24, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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