Schizophrenia
Conditions
Keywords
Schizophrenia, Treatment-resistant, sertindole, clozapine
Brief summary
The purpose of the study is to determine whether addition of sertindole to clozapine treatment can improve psychosis or the metabolic side-effects of clozapine in patients with treatment-resistant schizophrenia.
Detailed description
Around 20 % of patients with schizophrenia are treatment-resistant. Clozapine is still the drug of choice for these patients but 2/3 will not respond adequately to clozapine. In the study clozapine treatment is augmented with sertindole. Patients are randomized to either clozapine or sertindole for 12 weeks and continue in a open-label study with sertindole for 12 weeks. The purpose of the open-label study is to determine whether clozapine dosage can be reduced due to the addition of sertindole.
Interventions
DRUGSerdolect
16 mg, 12 weeks
DRUGplacebo
placebo
Sponsors
H. Lundbeck A/S
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ICD10 diagnosis of schizophrenia (F20.0-3) * Clozapine treatment minimum 6 months * Total PANSS \>65 * No antipsychotic other than clozapine drug 1 month prior inclusion
Exclusion criteria
* QTc \>500 ms * Violence to SPC of clozapine or Serdolect * Major depression * Significant substance misuse interfering with participating in the study * Cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PANSS total score | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| WHOQOL-BREF | 12 weeks |
| CGI | 12 weeks |
| DAI | 12 weeks |
| GAF | 12 weeks |
| Fasting glucose | 12 weeks |
| Lipids | 12 weeks |
| Hb1Ac | 12 weeks |
| Cognitive test | 12 weeks |
Countries
Denmark
Outcome results
None listed