Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395031
Status:
COMPLETED
Last Update Posted:
2011-07-29
First Post:
2006-11-01
Brief Title:
Effect of Ziprasidone on Glucose Plasma Lipids in Diabetes II and Schizophrenia or Schizoaffective Disorder
Sponsor:
Manhattan Psychiatric Center
Organization:
Manhattan Psychiatric Center
Study Overview
Official Title:
The Effects of Ziprasidone 320 mg on Glucose and Plasma Lipids in Patients With Diabetes Type II and Schizophrenia or Schizoaffective Disorder
Status:
COMPLETED
Status Verified Date:
2011-07
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:
The aim of the protocol is to study the effects of 320 mgday of ziprasidone Geodon on glucose and lipid metabolism of patients with both Diabetes Type II DM and schizophrenia or schizoaffective disorder after switching their antipsychotic medications from typical andor atypical to ziprasidone monotherapy
Detailed Description:
Inpatients with DSM IV diagnosis of schizophrenia or schizoaffective disorder and DM II will be enrolled after giving informed consent Participants may stay on their original ward at MPC if their clinical care would be better served on their home ward because of patient programs andor continuity of care reasons Patients recruited from other participating sites will be transferred to MPC research ward
There will be a screening phase two weeks on the prior antipsychotic regimen a cross-titration phase three week and a ziprasidone phase eight weeks four time points
All medications except for the antipsychotic agents will be kept stable throughout the protocol These medications may include anticholinergics mood stabilizers and antidepressants After the screening phase lasting two weeks patients will enter the cross-titration phase lasting three week The cross titration schedule will be changed in accordance with Deutschman Deutschmans 2005 recommendations The current antipsychotic will be gradually decreased to zero and ziprasidone will be started at 40 mg bid po and raised up to 160 mg po bid during the cross-titration phase according to clinical response and tolerance After the cross-titration phase has concluded the ziprasidone dose will range from 80 mg bid po to 160 mg bid po daily according to clinical response during the eight week treatment phase
There will be a screening phase two weeks on the prior antipsychotic regimen a cross-titration phase three week and a ziprasidone phase eight weeks four time points
All medications except for the antipsychotic agents will be kept stable throughout the protocol These medications may include anticholinergics mood stabilizers and antidepressants After the screening phase lasting two weeks patients will enter the cross-titration phase lasting three week The cross titration schedule will be changed in accordance with Deutschman Deutschmans 2005 recommendations The current antipsychotic will be gradually decreased to zero and ziprasidone will be started at 40 mg bid po and raised up to 160 mg po bid during the cross-titration phase according to clinical response and tolerance After the cross-titration phase has concluded the ziprasidone dose will range from 80 mg bid po to 160 mg bid po daily according to clinical response during the eight week treatment phase
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Pfizer Reference 2001-0448 | OTHER_GRANT | Pfizer Inc | None |