Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD)

NCT00880919 | Completed Phase 3 Results DMC

• 2 other identifiers: 0709M16844IRUSQUET0454
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 3

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 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 Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD), an objective rating scale that addresses the severity of Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (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.

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality Disorder; BPD; Seroquel; Seroquel XR; quetiapine; quetiapine extended-release

Outcome Measures

Primary Outcomes (9)

• Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)

  This is an assessment of change in DSM-IV borderline psychopathology. Consisting of nine criteria rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. 0 being the best and 4 meaning the worse.

  baseline, weekly until week 8

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  Nine criteria rated on a six-point anchored rating scale of 0 to 6, yielding a total score of 0 to 60. O is the least and 6 is the highest 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression.

  baseline to 8 weeks

• Borderline Evaluation of Severity Over Time (BEST)

  Scale including 15 items and three subscales. All items are rated on a Likert-like scale. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst).

  Baseline to 8 weeks

• Overt Aggression Scale - Modified (OAS-M)

  Four part behavior rating scale designed to measure four types of aggressive behavior as witnessed in the past week. Each section consists of five questions. Total scores on the MOAS range from 0-40. 0 is the best and 40 is the worst of symptoms Reduction in scores shows a change of symptoms.

  Change from Baseline Overt Aggression Scale - Modified to 8 weeks

• Global Assessment of Functioning Scale (GAF)

  Numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults. 100 is the highest level of functioning. O is the least functional

  Change in Global Assessment of Functioning from Baseline to 8 weeks

• Barratt Impulsiveness Scale (BIS)

  30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors. patients rate the questions 1-4 1 being the least and 4 being the most.

  Change in Impulsiveness from Baseline to 8 weeks

• Symptom Checklist -90-Revised (SCL-90-R)

  90 items measured on a Likert scale via self-report. Scale is 0-5 stating 0= strongly disagree and 5 is Strongly agree Measures psychological problems and symptoms

  Change in psychological problems and symptoms from Baseline to 8 weeks

• Young Mania Rating Scale (YMS)

  Eleven-item multiple choice diagnostic questionnaire, yielding total scores of 0-60. 0-4 rating 0-being least likely and 4 being most likely This scale assess manic symptoms

  Change in manic symptoms from Baseline to 8 weeks

• Sheehan Disability Scale (SDS)

  Three self-rated items, on a scale of 0-10. 0 is unimpaired 10 is highly impaired This measures functional impairment

  Change in functional impairment from Baseline to 8 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

Seroquel XR 150mg oral tablets taken daily for 8 weeks.

Drug: quetiapine extended-release

2

ACTIVE COMPARATOR

Seroquel XR 300mg oral tablets taken daily for 8 weeks.

Drug: quetiapine extended-release

3

PLACEBO COMPARATOR

Equivalent number of placebo oral tablets taken daily for 8 weeks.

Drug: Placebo

Interventions

quetiapine extended-release DRUG

Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo

Also known as: Seroquel XR

1; 2

Placebo DRUG

Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo

Also known as: quetiapine extended-release

3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or lactation
• 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

Sponsors & Collaborators

• University of Minnesota: lead
• AstraZeneca: collaborator
• University of Iowa: collaborator
• Mclean Hospital: collaborator

Study Sites (3)

University of Iowa, Department of Psychiatry

Iowa City, Iowa, 52242, United States

Location

McLean Hospital, Harvard Medical School, Department of Psychiatry

Belmont, Massachusetts, 02478, United States

Location

University of Minnesota Medical Center, Fairview Riverside

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

• 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.

  PMID: 36375174 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. S. Charles Schulz, MD
• Organization: University of Minnesota

scs@umn.edu

612-273-9820

Study Officials

• S. Charles Schulz, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2009
• First Posted: April 14, 2009
• Study Start: June 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 9, 2017
• Results First Posted: December 28, 2016

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)