Augmenting Clozapine With Sertindole - SERCLOZ

University of Aarhus

Status: Completed

Conditions: Schizophrenia

Treatments: Drug: placebo; Drug: Serdolect

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00345982

2005/150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Sertindole 16 mg

Treatment:

Drug: Serdolect

B

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo