High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
The primary aims of this study are to assess tolerability of ziprasidone dose escalation to
320 milligrams per day (mg/d) compared to continued standard treatment (placebo) as measured
by the Side Effect Checklist, Simpson Angus Scale for Extrapyramidal Symptoms (SAS), Barnes
Akathisia Scale (BAS), serum prolactin concentrations, vital signs, electrocardiogram (EKG)
and completion rates and to assess whether ziprasidone dose escalation improves overall
psychopathology compared to continued standard treatment as measured by the change from
baseline in the Positive and Negative Syndrome Scale (PANSS) total score and response rates
as defined by a 20% or greater reduction in PANSS total score.
The secondary aims of this study are to assess whether ziprasidone dose escalation improves
psychotic symptoms compared to continued standard treatment as measured by the Positive
Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves
negative symptoms compared to standard treatment as measured by the Negative Symptom Subscale
of the PANSS, to assess whether ziprasidone dose escalation improves depressive symptoms
compared to continued standard treatment as measured by the Calgary Depression Rating Scale
(CDRS), and to assess whether ziprasidone dose escalation improves overall functioning with
the Clinical Global Impression - Severity (CGI-S), Clinical Global Impression - Improvement
(CGI-I), Global Assessment of Functioning (GAF) and the Schizophrenia Cognition Rating Scale
(SCoRS).