Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00297947
Status:
COMPLETED
Last Update Posted:
2015-04-17
First Post:
2006-02-27
Brief Title:
High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder
Sponsor:
Manhattan Psychiatric Center
Organization:
Manhattan Psychiatric Center
Study Overview
Official Title:
A Randomized Double-Blind Parallel-Group Fixed Dose Clinical Trial of Quetiapine 600 mgDay vs 1200 mgDay for Patients With Treatment-Resistant Schizophrenia or Schizoaffective Disorder
Status:
COMPLETED
Status Verified Date:
2015-04
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:
HDQ
Brief Summary:
This study will investigate the safety and efficacy of quetiapine in sub-optimally responding patients with DSM-IV schizophrenia using a double blind randomized 12-week trial comparing oral doses of 1200 mgd to 600 mgd of quetiapine
Detailed Description:
The study will be conducted at two sites Manhattan Psychiatric Center MPC and the Clinical Research and Evaluation Facility at the Nathan S Kline Institute for Psychiatric ResearchRockland Psychiatric Center NKI A total of 60 patients will be enrolled 30 at each location After a screening period of 1 week all patients will be entering an open label four-week quetiapine treatment period run-in phase during which quetiapine will be titrated to 600 mg PO daily and other adjunctive antipsychotics will be gradually tapered and discontinued Other concomitant medications such as mood stabilizers will be maintained if their dose has been stable for the preceding 2 months Patients not responding to quetiapine treatment at 600 mg PO defined as reduction of 15 change in Positive and Negative Syndrome Scale PANSS total score between start of run-in to end of week 4 during the run-in phase will be eligible to enter the double blind phase Study baseline will be Day 7 of Week 4 of the run-in phase Patients qualifying for the double-blind phase will be randomly assigned to either high dose 1200 mg quetiapine daily Group A or to 600 mg quetiapine Group B daily and treated on the assigned dose in a double blind fashion for 8 weeks Week 1 through Week 8 of double blind phase Measures of extra-pyramidal side effects psychopathology and safety will be conducted throughout the trial
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