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Augmenting clozapine with sertindole: a double-blind, randomized, placebo-controlled study.

Jimmi Nielsen¹, Charlotte Emborg, Susanne Gydesen

¹Unit for Psychiatric Research, Aalborg Psychiatric Hospital, Aarhus University Hospital, Aalborg, Denmark. jin@rn.dk

Journal of Clinical Psychopharmacology

|February 28, 2012

Summary

Clozapine augmentation with sertindole did not improve schizophrenia symptoms compared to placebo. This antipsychotic augmentation strategy showed no benefits and may worsen psychosis in some patients.

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Area of Science:

Psychiatry
Pharmacology

Background:

Clozapine is effective for treatment-resistant schizophrenia, but many patients require augmentation.
Antipsychotic augmentation strategies are common, yet evidence is limited.
Sertindole, a nonsedating atypical antipsychotic, was investigated for clozapine augmentation due to its receptor affinity profile.

Purpose of the Study:

To evaluate the efficacy and safety of sertindole augmentation in patients with schizophrenia inadequately responding to clozapine.

Main Methods:

A 12-week, double-blind, randomized, placebo-controlled trial.
Included patients with International Classification of Diseases, 10th Revision schizophrenia (F20.0-F20.3) on stable clozapine therapy.
Assessed outcomes using the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI), and other measures.

Main Results:

Sertindole augmentation was not superior to placebo on PANSS total or subscale scores, CGI, or quality of life measures.
No significant increase in adverse effects was observed compared to placebo.
Four patients on sertindole experienced psychosis worsening, with two requiring hospitalization.
A statistically significant QTc prolongation (12 ms) was noted in the sertindole group versus placebo.

Conclusions:

Clozapine augmentation with sertindole offers no demonstrated benefit over placebo for patients with schizophrenia.
The strategy may carry risks, including potential worsening of psychosis and QTc prolongation.
Clinicians should carefully consider the lack of efficacy and potential risks before using sertindole augmentation.