Phase 4
Completed N=40
Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics
Source: ClinicalTrials.gov NCT00458211 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
May 2013
Primary outcomePrimary: Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia — 95; 99; 72; 62 score on scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia |
95; 99; 72; 62 | — |
| SECONDARY Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness. |
4.6; 4.9; 3.5; 2.8 | — |
| SECONDARY Weight |
195; 193; 213; 204 | — |
| SECONDARY Fasting Glucose |
91; 82; 94; 93 | — |
| SECONDARY Cholesterol |
185; 160; 186; 179 | — |
| SECONDARY Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia |
0.3; 0.3; 2.9; 1.6 | — |
| SECONDARY Simpson-Angus Scale Measures Drug Induced Parkinsonism |
0.2; 0.1; 3.6; 2.5 | — |
| SECONDARY Corrected QT Interval (QTc) |
396; 411; 412; 427 | — |
| SECONDARY Brief Assessment of Cognition in Schizophrenia (BACS) |
-14; -13; -12; -11 | — |
| SECONDARY Calgary Depression Scale for Schizophrenia |
5.4; 5.3; 3.4; 1.3 | — |
| SECONDARY Personal Evaluation of Transitions in Treatment Scale (PETiTP |
43; 45; 46; 48 | — |
| SECONDARY Medical Outcomes Study Cognitive Functioning Scale (MOS-COG) |
17; 16; 18; 19 | — |
| SECONDARY Barnes Akathisia Scale |
0.6; 0.8; 1.4; 1.1 | — |
| SECONDARY HbA1c |
5.3; 5.4; 6.0; 5.7 | — |
| SECONDARY Insulin Level |
10; 13; 12; 17 | — |
| SECONDARY Antipsychotic Medication Costs |
— | — |
Eligibility Criteria
Inclusion Criteria
- Schizophrenia or schizoaffective
- Capacity to give consent
- Stable, on the same medication for a month but only partial response or with unacceptable side effects 18-65 years of age
Exclusion Criteria
- Repeated non-compliance
- Current depot medication
- Active medical conditions
- QTc >500msec
- Previous non-response
- Previous treatment with ziprasidone
Data sourced from ClinicalTrials.gov (NCT00458211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.