Condition category
Mental and Behavioural Disorders
Date applied
01/08/2006
Date assigned
31/08/2006
Last edited
05/09/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jaroslav Malevani

ORCID ID

Contact details

Bergische Landstrasse 2
Duesseldorf
40629
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D1449L00014

Study information

Scientific title

Acronym

QuBor Study

Study hypothesis

The objective of this randomised, rater blinded study is to compare the efficacy of two currently frequently used substances, the Selective Serotonin Reuptake Inhibitors (SSRI) sertraline and the atypical neuroleptic quetiapine, in the treatment of borderline personality disorder. It is the hypothesis of this study that the atypical neuroleptic quetiapine favorably affects a broader spectrum of the borderline psychopathology than sertraline. The pharmacotherapy should be accompanied by psychotherapy that is based on the dialectical behavior therapy of Linehan. This study will contribute to optimising the medication therapy of borderline personality disorder with respect to efficiency and clarity.

The hypothesis regarding the efficacy comparison of quetiapine and sertraline is that quetiapine is significantly superior to treatment with SSRIs in the therapy of the following target symptoms: impulsivity, aggressiveness, self-inflicted injuries/self-harming and suicidal behavior.

Ethics approval

Ethics approval is pending from the University of Duesseldorf.

Study design

Randomised, rater-blinded trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Borderline Personality Disorder

Intervention

Intervention group one: Quetiapin 50-800 mg per day orally over 24 weeks.
Intervention group two: Sertralin 25-200 mg per day orally also over 24 weeks.

Intervention type

Drug

Phase

Not Specified

Drug names

Quetiapine and sertraline

Primary outcome measures

The primary assessment instrument will be the Symptom Check List 90 (SCL-90R) and the primary outcome parameter will be the anger/hostility subscale of the SCL-90R.

Secondary outcome measures

1. Severity of affective symptoms
2. Anxiety and depressive symptoms
3. Psychotic or psychosis-like symptoms
4. Interpersonal problems
5. Duration of hopsitalisation
6. Co-medication

Overall trial start date

01/10/2006

Overall trial end date

15/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Borderline personality disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
2. At least 18 years of age
3. Voluntary legal basis
4. Female
5. Written informed consent before entering the study
6. No relevant abnormalities in Electrocardiogram (ECG) and laboratory tests

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

54

Participant exclusion criteria

1. Lifetime diagnosis of schizophrenia or schizoaffective disorder according to DSM IV
2. Lifetime diagnosis of bipolar disorder according to DSM IV
3. Current severe major depressive episode according to DSM IV
4. Current severe somatic illness
5. Current psychotic disorder due to substance disorder or a general medical condition
6. Use of drugs that induce or inhibit the metabolising cytochrome 3A4 enzymes within two weeks prior to week zero and during the course of the study (e.g. inducers: phenytoin, carbamazepin, phenobarbital, rifampin, rifabutin, glucocorticoids, thioridazine and St. John´s wort and inhibitors: ketokonazole [except for topical use], itraconazole, fluconazole, erythromycin, fluvoxamin, nefadozone, troleandomycin, indinavir, nelfinavir, ritonavir and saquinavir)

Recruitment start date

01/10/2006

Recruitment end date

15/03/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Bergische Landstrasse 2
Duesseldorf
40629
Germany

Sponsor information

Organisation

University of Duesseldorf (Germany)

Sponsor details

Faculty of Medicine
c/o Prof Dr Nuernberg
Universitaetsstrasse 1
Duesseldorf
40225
Germany

Sponsor type

University/education

Website

http://medfak.uniklinikum-duesseldorf.de/

Funders

Funder type

Industry

Funder name

AstraZeneca

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes