Verkes Borderline Study: The Effect of Quetiapine on Borderline Personality Disordered Patients

NCT ID: NCT00254748

Last Updated: 2009-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2007-06-30

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.

Conditions

Borderline Personality Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

2

Flexible doses of 200 mg/day to 600 mg/day quetiapine fumarate

Group Type: EXPERIMENTAL

Quetiapine fumarate

Intervention Type: DRUG

flexible doses from 200 mg to 600 mg

Interventions

Quetiapine fumarate

flexible doses from 200 mg to 600 mg

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Other Intervention Names

Seroquel; 204,636

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

AstraZeneca Netherlands Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Research Site

Apeldoorn, , Netherlands

Research Site

Nijmegen, , Netherlands

Research Site

Veghel, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 36375174 (View on PubMed)

Other Identifiers

D1441C00003

Identifier Type: -

Identifier Source: org_study_id