Verkes Borderline Study: The Effect of Quetiapine on Borderline Personality Disordered Patients - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00254748

Purpose

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.

Condition	Intervention	Phase
Borderline Personality Disorder	Drug: Quetiapine fumarate Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Personality Disorders Psychotic Disorders

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms [ Time Frame: assessed at each visit for 8 weeks ]

Secondary Outcome Measures:

To explore the effect of quetiapine on mood, anger, impulsiveness, hostility and anxiety in patients with BPD [ Time Frame: assessed at each visit for 8 weeks ]

Estimated Enrollment:	40
Study Start Date:	June 2004
Study Completion Date:	June 2007

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Placebo placebo
2: Experimental Flexible doses of 200 mg/day to 600 mg/day quetiapine fumarate	Drug: Quetiapine fumarate flexible doses from 200 mg to 600 mg

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254748

Locations

Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Apeldoorn, Netherlands
Research Site
Veghel, Netherlands

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Netherlands Medical Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D1441C00003
Study First Received:	November 15, 2005
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00254748 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:

Borderline personality disorder

Additional relevant MeSH terms:

Quetiapine
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Borderline Personality Disorder
Central Nervous System Agents
Pharmacologic Actions
Personality Disorders

ClinicalTrials.gov processed this record on November 20, 2009