Treatment resistant schizophrenia MedDRA version: 8.1 Level: LLT Classification code 10039638 Term: Schizophrenia, disorganised type
Conditions
Interventions
Trade Name: Serdolect 4 mg
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Serdolect 12 mg
Pharmaceutical Form: Tab
Sponsors
Aalborg Psychiatric Hospital, Research Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Denmark
Outcome results
None listed