Quetiapine versus sertraline as the pharmacological component in a standardised psychopharmacological and psychotherapeutic treatment of borderline personality disorder: a randomised, rater-blinded study
| ISRCTN | ISRCTN11135486 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11135486 |
| Secondary identifying numbers | D1449L00014 |
- Submission date
- 01/08/2006
- Registration date
- 31/08/2006
- Last edited
- 05/09/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Jaroslav Malevani
Scientific
Scientific
Bergische Landstrasse 2
Duesseldorf
40629
Germany
Study information
| Study design | Randomised, rater-blinded trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study 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(s) | Ethics approval is pending from the University of Duesseldorf. |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Quetiapine and sertraline |
| Primary outcome measure | 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 study start date | 01/10/2006 |
| Overall study end date | 15/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 54 |
| 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 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
Study participating centre
Bergische Landstrasse 2
Duesseldorf
40629
Germany
40629
Germany
Sponsor information
University of Duesseldorf (Germany)
University/education
University/education
Faculty of Medicine
c/o Prof Dr Nuernberg
Universitaetsstrasse 1
Duesseldorf
40225
Germany
| Website | http://medfak.uniklinikum-duesseldorf.de/ |
|---|---|
"ROR" |
https://ror.org/024z2rq82 |
Funders
Funder type
Industry
AstraZeneca
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
