At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of schizophrenia or schizoaffective disorder, any subtype
- ✓Age 18-65 years
- ✓Already treated with ziprasidone 160 mg/day for at least 3 weeks with adequate compliance
- ✓Moderate or greater positive symptoms (PANSS score ≥4 on any of 7 positive symptom items) despite adequate ziprasidone treatment
- ✕History of intolerance to ziprasidone side effects
- ✕Significant cardiac disease including uncompensated heart failure, myocardial infarction within 6 months, or congenital long QT syndrome
- ✕QTc interval ≥500 msec
- ✕Serum potassium or magnesium outside normal limits
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
High-Dose Oral Ziprasidone Versus Conventional Dosing in Schizophrenia Patients With Residual Symptoms
In Brief
A Phase 3 clinical trial evaluating Ziprasidone 80-160 mg/d, Placebo, and 1 other intervention for Schizophrenia. Completed, enrolled 131 participants across 9 sites.
Detailed 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).
Study Details
Timeline
Interventions
Participants will be instructed to take one study capsule of ziprasidone orally twice daily (80 mg/d). After the first week, the study drug will be increased to two capsules twice daily (160 mg/d).
Participants will be instructed to take one study capsule of matching placebo orally twice daily. After the first week, the matching placebo will be increased to two capsules twice daily.
Participants will be taking open-label ziprasidone 80 mg orally twice daily for a total dose of 160 mg/d from at least 3 weeks before randomization to end of study 8 weeks after randomization.