Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403546
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2006-11-21
Brief Title:
High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms
Sponsor:
Donald C Goff MD
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
High-Dose Oral Ziprasidone Versus Conventional Dosing in Schizophrenia Patients With Residual Symptoms
Status:
COMPLETED
Status Verified Date:
2017-06
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:
HDZ
Brief Summary:
The primary aims of this study are to assess tolerability of ziprasidone dose escalation to 320 milligrams per day mgd 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
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
Detailed Description:
None
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