Phase 4
Completed N=241
Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone
Source: ClinicalTrials.gov NCT00406315 ↗Enrolled (actual)
241
Serious AEs
9.1%
Results posted
Feb 2010
Primary outcomePrimary: Change From Baseline in Weight at Week 16 — -1.09; -0.73 kilogram
Summary
The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weight at Week 16 |
-1.09; -0.73 | — |
| SECONDARY Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16 |
-3.0 | — |
| SECONDARY Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16 |
-0.2; -2.5; -1.6 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16 |
0.1 | — |
| SECONDARY Change From Baseline in Fasting Glucose at Week 16 |
3.0 | — |
| SECONDARY Change From Baseline in Fasting Insulin at Week 16 |
134.8 | — |
| SECONDARY Change From Baseline in Waist and Hip Circumference at Week 16 |
-2.9; -3.0 | — |
| SECONDARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16 |
0.05; 0.03; 0.01 | — |
| SECONDARY Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16 |
-10.22; -6.61; -3.30; -2.43; -1.67; -0.92 | — |
| SECONDARY Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16 |
-0.76; -0.47 | — |
| SECONDARY Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16 |
2.7; 3.2 | — |
| SECONDARY Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16 |
-2.55; -1.58 | — |
| SECONDARY Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16 |
-4.61; -4.21; -1.02; -0.88 | — |
| SECONDARY Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16 |
7.88; 5.27 | — |
| SECONDARY Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16 |
10.49; 10.49; 18.49; 18.49; 6.45; 6.45 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females, between 18 and 55 years of age, at the time of consent.
- Subjects must have a primary diagnosis of schizophrenia, any subtype (code 295.xx), or schizoaffective disorder as defined in DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition)
- Subjects must have normal vital signs, physical examination, ECG, and laboratory findings except for minor deviations determined and documented to be clinically insignificant by the investigator or a sub-investigator who is a medical doctor.
Exclusion Criteria
- Subjects who are unable to provide informed consent
- Subjects who meet criteria for a DSM-IV-TR Axis I (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) diagnosis other than schizophrenia or schizoaffective disorder, including psychoactive substance abuse or dependence within one year of study entry
- Females who are pregnant, breast feeding, or lactating at screening.
Data sourced from ClinicalTrials.gov (NCT00406315). 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.