Augmenting clozapine with sertindole - A double-blinded randomized placebo study (SERCLOZ) - SERCLOZ
- Conditions
- Treatment resistant schizophreniaMedDRA version: 8.1Level: LLTClassification code 10039638Term: Schizophrenia, disorganised type
- Registration Number
- EUCTR2006-002682-40-DK
- Lead Sponsor
- Aalborg Psychiatric Hospital, Research Unit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Both sexes, 18-65 years.
Minimum treatment with clozapine for six months
Fixed dosage dosage of clozapine and other psychotropics last month prior inclusion except for benzodiazepines and anticholinergics.
No other antipsychotic during the study than sertindole and clozapine
PANSS score more than 65
Informed consent given
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Clinical important cardiovascular disease
Prescribing other antipsychotics than clozapine
Compulsory measures
QT prolongation to more than 500 ms.
Concomitant potent CYP2D6 inhibitors
ICD-10 Major depression
Disruption of clozapine bloodsamples
Pregnancy
Disruption of SPC of Serdolect and clozapine
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate whether adding sertindole to clozapine therapy can improve symptoms in schizophrenia.;Secondary Objective: To investigate whether adding sertindole to clozapine can make it possible to decrease to dosage of clozapine and thereby decrease dose-dependent side-effects.;Primary end point(s): A 10 % reduction on Positive and Negative syndrome scale (PANSS) after 12 weeks.
- Secondary Outcome Measures
Name Time Method