Quetiapine versus sertraline as the pharmacological component in a standardised psychopharmacological and psychotherapeutic treatment of borderline personality disorder: a randomised, rater-blinded study

Completed

• Conditions: Borderline Personality Disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN11135486
• Lead Sponsor: niversity of Duesseldorf (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-31
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 54

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified