Schizophrenia Clinical Trial
Official title:
Evaluation of Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotic Medications
Because ziprasidone has not been extensively studied and is not widely accepted in the
severely mentally ill in State hospitals this study aims to demonstrate its effectiveness and
relative lack of side effects. 75 patients with schizophrenia or schizoaffective disorder who
need a change of medication because of ineffectiveness or side effects will be changed to
ziprasidone and followed with detailed assessments for eight weeks.
The hypothesis is that they will improve and have fewer side effects.
Ziprasidone has been found in studies and practice to be efficacious and tolerated well but
has not been well studied or well accepted in the very severely ill in State Hospitals. This
study aims to fill that gap by examining 75 patients with schizophrenia or schizoaffective
disorder who require a change of medication because of poor response or unacceptable side
effects.
After signing consent and having a baseline assessment they will, if necessary, be reduced to
one antipsychotic then started on ziprasidone, increasing to 160mg the second day. The one
antipsychotic they had been on will be reduced over a week and stopped. The ziprasidone can
be increased to 240mg after three weeks if necessary.
The study will last eight weeks with efficacy assessed by Clinical Global Impressions (CGI),
Positive and Negative Syndrome Scale (PANSS) every two weeks and Brief Assessment of
Cognition, Calgary Depression Scale for Schizophrenia, Personal Evaluation of Transitions in
Treatment and Medical Outcomes Study Cognitive Questions at the beginning and end. Side
effects will be measured by movement disorder scales (Simpson-Angus scale for Parkinsonism
(SANRS), Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Scale (BAS)), ECG
and weight and blood metabolic measures.
The hypothesis is that ziprasidone will be generally effective and that side effects
especially metabolic indices will be reduced.
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