Clinical trial NCT00254748: Verkes Borderline Study: The Effect of Quetiapine on Borderline Personality Disordered Patients
Official title: The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Borderline Personality Disorder
Keywords: Borderline personality disorder
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms
timeFrame: assessed at each visit for 8 weeks
Secondary outcomes:
measure: To explore the effect of quetiapine on mood, anger, impulsiveness, hostility and anxiety in patients with BPD
timeFrame: assessed at each visit for 8 weeks
Other outcomes:
Locations:
city: Apeldoorn
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Veghel
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Netherlands Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.