Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD) - Full Text View

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
Collaborators:	AstraZeneca University of Iowa Mclean Hospital
Information provided by (Responsible Party):	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00880919

Purpose

The Primary objective of this study is to evaluate Seroquel XR in the treatment of BPD. As in many initial RCTs, the study will be of relatively short duration - 8 weeks - to assess effectiveness and safety while maximizing retention. The specific aim is to determine if Seroquel XR is superior to placebo. The primary outcome measure will be a statistically significant difference between Seroquel XR compared to placebo on the ZAN-BPD, an objective rating scale that addresses the severity of DSM-IV symptoms of the illness. As there is the recent development of an extended release form of Seroquel (Seroquel XR) (Schulz et al. 2007), the new compound may offer several advantages in this study. Therefore, the hypothesis of this study is that both doses of Seroquel XR (see below) will be superior to placebo in an 8-week randomized trial as assessed by the ZAN-BPD.

To achieve the Primary Objective of this study, two doses of Seroquel XR will be tested - 150 mg/d and 300 mg/d. Thus, the study will be able to assess the effect of Seroquel XR compared to placebo and to explore a dose effect.

Condition	Intervention	Phase
Borderline Personality Disorder	Drug: quetiapine extended-release Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Seroquel XR for the Management of Borderline Personality Disorder (BPD)

Resource links provided by NLM:

MedlinePlus related topics: Personality Disorders

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

The Primary objective of this study is to determine if Seroquel XR is superior to placebo. The primary outcome measure will be a statistically significant difference between Seroquel XR. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To be able to report the safety of Seroquel XR for BPD. Objectively, weight, height (and BMI), prolactin, glucose, cholesterol and triglycerides will be assessed at baseline and endpoint. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	99
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Seroquel XR 150mg oral tablets taken daily for 8 weeks.	Drug: quetiapine extended-release Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo Other Name: Seroquel XR
Active Comparator: 2 Seroquel XR 300mg oral tablets taken daily for 8 weeks.	Drug: quetiapine extended-release Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo Other Name: Seroquel XR
Placebo Comparator: 3 Equivalent number of placebo oral tablets taken daily for 8 weeks.	Drug: Placebo Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo Other Name: quetiapine extended-release

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:

Response rate: In previous studies using the ZAN-BPD, response was defined as a 50% reduction of ZAN-BPD scores. Response rates will be compared between Seroquel XR and placebo.
Other Symptom Measures: Over the last twenty years, other rating scales of a general nature have been used to assess BPD patients in clinical trials. To fully assess the patients as they progress through the study, the following scales will be administered: Symptom Checklist 90 - Revised (SCL-90 R), Montgomery Asberg Depression Rating Scale (MADRS), Barratt Impulsivity Scale (BIS), Schedule for Interviewing Borderlines (SIB), Overt Aggression Scale - Modified (OAS-M), Young Mania Rating Scale (YMRS), the Borderline Evaluation of Severity over Time (BEST), and the Global Assessment of Function (GAF).
Side-Effects: To be able to report the safety of Seroquel XR for BPD, a combination of objective and subjective measures will be employed. Objectively, weight, height (and BMI), prolactin, glucose, cholesterol and triglycerides will be assessed at baseline and endpoint. Objective ratings of movement side effects will be performed using Simpson Angus Scale (SAS) (Simpson and Angus 1970), Barnes Akathisia Scale (BAS) (Barnes 1989), and Abnormal Involuntary Movement Scale (AIMS) (Guy 1976), and at baseline and endpoint. Regarding possible side effects reported by patients, their reports of headache, somnolence, and other experiences will be tabulated.

Secondary objective data will be analyzed as continuous variable data over the time of the study or, when appropriate, comparisons of baseline to endpoint will be made.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880919

Contacts

Contact: Ann S Romine, RN

612-627-4809

romi0004@umn.edu

Locations

United States, Iowa
University of Iowa, Department of Psychiatry	Recruiting
Iowa City, Iowa, United States, 52242
Contact: Donald Black, MD 319-353-4431 donald-black@uiowa.edu
Contact: Martha Shaw, BA 319-353-3904 martha-shaw@uiowa.edu
Sub-Investigator: Donald W Black, MD
United States, Massachusetts
McLean Hospital, Harvard Medical School, Department of Psychiatry	Terminated
Belmont, Massachusetts, United States, 02478
United States, Minnesota
University of Minnesota Medical Center, Fairview Riverside	Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Ann Romine, RN 612-627-4843 romi0004@umn.edu
Principal Investigator: S. Charles Schulz, MD

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

AstraZeneca

University of Iowa

Mclean Hospital

Investigators

Principal Investigator:

S. Charles Schulz, MD

University of Minnesota - Clinical and Translational Science Institute

More Information

No publications provided

Responsible Party:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00880919 History of Changes
Other Study ID Numbers:	0709M16844, IRUSQUET0454
Study First Received:	April 10, 2009
Last Updated:	August 30, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:

Borderline Personality Disorder
BPD
Seroquel

Seroquel XR
quetiapine
quetiapine extended-release

Additional relevant MeSH terms:

Personality Disorders
Borderline Personality Disorder
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012