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Borderline Personality DisorderPhase 3NCT00880919

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

A Phase 3 study testing quetiapine extended-release in people with Borderline Personality Disorder, run by University of Minnesota at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Borderline Personality Disorder
What is being tested?
quetiapine extended-release
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
95 participants
Where
3 sitesUnited States
Study dates
Jun 2008to Mar 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • McLean Hospital, Harvard Medical School, Department of Psychiatry

    Belmont, Massachusetts, 02478

  • University of Iowa, Department of Psychiatry

    Iowa City, Iowa, 52242

  • University of Minnesota Medical Center, Fairview Riverside

    Minneapolis, Minnesota, 55454

Other trials in United States

About this study

Official title: Seroquel XR for the Management of Borderline Personality Disorder (BPD)

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.

Read the 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. 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.
  2. 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).
  3. 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 Body Mass Index (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.

Being tested
quetiapine extended-release, Placebo
Keywords
Borderline Personality Disorder, BPD, Seroquel, Seroquel XR, quetiapine, quetiapine extended-release
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.

  • quetiapine extended-releaseDrug

    Also called Seroquel XR

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

  • PlaceboDrug

    Also called quetiapine extended-release

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

Study groups in NCT00880919
Study groupRoleWhat they receive
1Active comparatorSeroquel XR 150mg oral tablets taken daily for 8 weeks.
Receives: Drug: quetiapine extended-release
2Active comparatorSeroquel XR 300mg oral tablets taken daily for 8 weeks.
Receives: Drug: quetiapine extended-release
3Placebo comparatorEquivalent number of placebo oral tablets taken daily for 8 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, weekly until week 8

  2. 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.

    Measured: baseline to 8 weeks

  3. 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).

    Measured: Baseline to 8 weeks

  4. 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.

    Measured: Change from Baseline Overt Aggression Scale - Modified to 8 weeks

  5. 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

    Measured: Change in Global Assessment of Functioning from Baseline to 8 weeks

  6. 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.

    Measured: Change in Impulsiveness from Baseline to 8 weeks

  7. 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

    Measured: Change in psychological problems and symptoms from Baseline to 8 weeks

  8. 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

    Measured: Change in manic symptoms from Baseline to 8 weeks

  9. 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

    Measured: Change in functional impairment from Baseline to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2009 (estimated)
  2. Study startJun 2008
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00880919
Sponsor's protocol ID
0709M16844
Other IDs
IRUSQUET0454
Status last verified
Jan 2017
First submitted
10 Apr 2009
Last updated
9 Mar 2017
Data monitoring committee
Yes
Individual data sharing
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 36375174

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing quetiapine extended-release in people with Borderline Personality Disorder, run by University of Minnesota at 3 sites in United States.

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 6 inclusion and 19 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 28 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (time frame: baseline, weekly until week 8). The study lists 9 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 NCT00880919, which also lists 1 linked publication.

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 9 Mar 2017.

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