Verkes Borderline Study: The Effect of Quetiapine on Borderline Personality Disordered Patients
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Borderline Personality Disorder
Intervention: Quetiapine fumarate (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): AstraZeneca Netherlands Medical Director, MD, Study Director, Affiliation: AstraZeneca
Summary
In patients with schizophrenia, 'atypical' antipsychotics such as clozapine may be effective
in the treatment of psychosis. In patients with borderline personality disorder (BPD), as
far as the investigators know, no well designed controlled studies have been performed on
the effect of one of the newer atypical antipsychotics on psychotic symptoms.
It is of interest to investigate the benefit of quetiapine treatment in these types of
patients. Quetiapine possibly gives less side-effects because of the expected lack of
elevated prolactin levels, which is of importance in this patient group, overrepresented by
young females. In this double blind, randomized, placebo controlled, 8 week, parallel group,
multi-center study, quetiapine (in flexible doses between 200 mg/day and 600 mg/day) will be
compared with the placebo.
Clinical Details
Official title: The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms
Secondary outcome: To explore the effect of quetiapine on mood, anger, impulsiveness, hostility and anxiety in patients with BPD
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with BPD according to Diagnostic and Statistical Manual of Mental Disorders
- Fourth Edition (DSM-IV)/Structured Clinical Interview for DSM-IV Axis II
Personality Disorders (SCID-II) including criterion 9: transient, stress related
paranoid ideation or severe dissociative symptoms.
- In- or outpatients
Exclusion Criteria:
- Depressive disorder
- Bipolar disorder
- Schizoaffective disorder/schizophrenia/delusional disorder/schizotypal personality
disorder
- Alcohol- or substance dependence
- Quetiapine doses >100mg od use in the past
Somatic:
- History of trauma capitis
- Visual and auditive disorders
- Neurological disorders (epilepsy)
- Pregnancy
- No adequate contraception
- History of cardial complaints/cardiological disorder
- Known sensitivity for quetiapine
Locations and Contacts
Research Site, Apeldoorn, Netherlands
Research Site, Nijmegen, Netherlands
Research Site, Veghel, Netherlands
Additional Information
Starting date: June 2004
Last updated: June 9, 2009
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