Dose Reduction and Ziprasidone for Refractory Schizophrenia

The participants of this clinical research project were patients who had severe disabling symptoms, such as aggressive behavior and/or deficit states. Most patients were involuntarily hospitalized in long-stay clinics. These patients had been prescribed various high-dose FGAs for many years. The overall aim of this study was to evaluate whether dose reduction or treatment with ziprasidone would improve clinical outcomes. None of the patients were using clozapine at baseline or had used clozapine in the past, even though they experienced refractory positive and negative symptoms for years. All participants had a DSM-IV diagnosis of schizophrenia or schizoaffective disorder based on a Structured Clinical Interview for DSM disorders (SCID). According to the inclusion criteria, they were older than 18 years, had persistent symptoms for at least 2 years, were on stable medication (no change 3 months prior to inclusion in the study), and were able to comply with the study protocol. All patients gave their consent to use oral capsules of medication or placebo. None had diseases that could pose a medical risk, such as a QTc interval of more than 500 ms, which increases the risk of ziprasidone-associated arrhythmias.
Throughout the study, study medication was given under double-blind conditions. The medication/placebo capsules were prepared by the Central Hospital Pharmacy in The Hague. They were identical in appearance, taste, and smell.