Status:
COMPLETED
Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD)
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
AstraZeneca
University of Iowa
Conditions:
Borderline Personality Disorder
Eligibility:
All Genders
18-45 years
Phase:
PHASE3
Brief Summary
The Primary objective of this study is to evaluate Seroquel XR in the treatment of borderline personality disorder (BPD). As in many initial randomized control trials, the study will be of relatively ...
Detailed Description
The secondary objectives in this study are aimed at answering further questions regarding symptom assessments, dosing strategies, and safety. The specific secondary objectives are listed below: 1. Re...
Eligibility Criteria
Inclusion
- Consent
- A diagnosis of borderline personality disorder (301.83)
- All subjects will have a ZAN-BPD greater or equal to 9 at randomization.
- Males and females aged 18-45 years
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment
- Able to understand and comply with the requirements of the study
Exclusion
- Pregnancy or lactation
- Any DSM-IV Axis I disorder not defined in the inclusion criteria. The patients with BPD may not have bipolar I disorder, schizophrenia, schizoaffective disorder, delirium, or dementia. Neither may they have current DSM-IV substance dependence.
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
- Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, and saquinavir
- Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization
- Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension, congestive heart failure) as judged by the investigator
- Involvement in the planning and conduct of the study
- Previous enrollment or randomization of treatment in the present study.
- Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements
- Unstable Diabetes Mellitus
- An absolute neutrophil count (ANC) of 1.5 x 109 per liter
- Past history of lack of response to an atypical antipsychotic medication or substantial previous side effects will be cause for exclusion.
- Any medical illness that would interfere with conduct of the study will be cause for exclusion.
- Pregnant or lactating women and women of childbearing potential not using medically accepted means of contraception.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00880919
Start Date
June 1 2008
End Date
March 1 2013
Last Update
March 9 2017
Active Locations (3)
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1
University of Iowa, Department of Psychiatry
Iowa City, Iowa, United States, 52242
2
McLean Hospital, Harvard Medical School, Department of Psychiatry
Belmont, Massachusetts, United States, 02478
3
University of Minnesota Medical Center, Fairview Riverside
Minneapolis, Minnesota, United States, 55454