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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11135486

Enrollment

Registered

2006-08-31

Start date

2006-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder Mental and Behavioural Disorders Borderline Personality Disorder

Interventions

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.

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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)

Design outcomes

Secondary

Measure	Time frame
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	—

Primary

Measure	Time frame
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.	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026