Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458211
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2007-04-06
Brief Title:
Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics
Sponsor:
Bronx Psychiatric Center
Organization:
Bronx Psychiatric Center
Study Overview
Official Title:
Evaluation of Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotic Medications
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
The hypothesis is that they will improve and have fewer side effects
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None