Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics
|ClinicalTrials.gov Identifier: NCT00458211|
Recruitment Status : Completed
First Posted : April 10, 2007
Results First Posted : May 6, 2013
Last Update Posted : August 10, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Drug: ziprasidone||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotic Medications|
|Study Start Date :||May 2005|
|Primary Completion Date :||April 2008|
|Study Completion Date :||April 2008|
Open label change to ziprasidone
Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks
- Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia [ Time Frame: Baseline to 8 weeks ]Minimum score 32 (best) maximum 210 (worst)
- Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness. [ Time Frame: 8 weeks ]CGI-S scores from 1 = normal to 7 = most extremely ill
- Weight [ Time Frame: 8 weeks ]
- Fasting Glucose [ Time Frame: 8 weeks ]
- Cholesterol [ Time Frame: 8 weeks ]
- Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia [ Time Frame: 8 weeks ]Scores 0 (none) to 4 (severe) choreo-athetoid and dystonic movements of seven parts of the body with a maximum score 28
- Simpson-Angus Scale Measures Drug Induced Parkinsonism [ Time Frame: 8 weeks ]Measures 10 signs, (not all of which are now considered Parkinsonism), minimum score 0 (no Parkinsonism) maximum 40.
- QTc [ Time Frame: 8 weeks ]Time interval between Q and T waves on EKG corrected for pulse rate. Over 500 msec may be dangerous
- BACS [ Time Frame: 8 weeks ]
- CDSS [ Time Frame: 8 weeks ]
- PETiT [ Time Frame: 8 weeks ]
- MOS-COG [ Time Frame: 8 weeks ]
- Barnes Akathisia Scale [ Time Frame: 8 weeks ]
- HgbA1c [ Time Frame: 8 weeks ]
- Insulin Level [ Time Frame: 8 weeks ]
- Antipsychotic Medication Costs [ Time Frame: 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458211
|United States, New York|
|Bronx Psychiatric Center|
|Bronx, New York, United States, 10461|
|Buffalo Psychiatric Center|
|Buffalo, New York, United States, 14213|
|Principal Investigator:||Nigel Bark, MD||Bronx Psychiatric Center|
|Principal Investigator:||Jeffrey Grace, MD||Buffalo Psychiatric Center|
|Principal Investigator:||Steven Schwarzkopf, MD||Rochester Psychiatric Center|