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 |
| Protocol serial number | D1449L00014 |
| Sponsor | University of Duesseldorf (Germany) |
| Funder | AstraZeneca |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Jaroslav Malevani
Scientific
Scientific
Bergische Landstrasse 2
Duesseldorf
40629
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, rater-blinded trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | QuBor Study |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Quetiapine and sertraline |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Severity of affective symptoms |
| Completion date | 15/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 54 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 15/03/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Bergische Landstrasse 2
Duesseldorf
40629
Germany
40629
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
