Ignite Creation Date:
2024-05-05 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00708396
Status:
UNKNOWN
Last Update Posted:
2009-01-27
First Post:
2008-07-01
Brief Title:
Tolerability And Efficacy Of High Dose Escitalopram In The Treatment Of Patients Suffering From Schizophrenia And Obsessive-Compulsive Disorder OCD - An Open Label Study
Sponsor:
BeerYaakov Mental Health Center
Organization:
BeerYaakov Mental Health Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2009-01
Last Known Status:
RECRUITING
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 purpose of the study is to evaluate tolerability and efficacy of escitalopram Cipralex treatment in doses beyond 20mg 20-40 mgd in patients with OCD and schizophrenia non responsive or partially responsive to recommended doses evaluation according to Y-BOCS
An open label prospective study The study will include 20 patients recruited from the inpatient wards and from the outpatient clinic who have a DSM-IV diagnosis of schizophrenia or schizoaffective disorder and OCD
Before entering the study all patients will be interviewed by 2 senior board certified psychiatrists in order to confirm the diagnosis of schizophrenia or schizoaffective disorder and OCD according to DSM-IV criteria
After confirming the diagnosis of schizophreniaschizoaffective disorder and OCD each patient will be evaluated by PANSS Y-BOCS and GCI-S scales Those patients who score above 12 points on the Y-BOCS will be eligible for the study
Rating scales PANSS Y-BOCS CGI-S CGI-I will be completed on a weekly basis during the whole 13 weeks period In addition patients will be asked to report medication side effects and will also be clinically evaluated for side effects by the physician Special attention will be paid to worsening of psychosis or OC symptoms All patients whose mental status will deteriorate or those who cannot tolerate the drug will be dropped-out and intent to treat analysis will be made
An open label prospective study The study will include 20 patients recruited from the inpatient wards and from the outpatient clinic who have a DSM-IV diagnosis of schizophrenia or schizoaffective disorder and OCD
Before entering the study all patients will be interviewed by 2 senior board certified psychiatrists in order to confirm the diagnosis of schizophrenia or schizoaffective disorder and OCD according to DSM-IV criteria
After confirming the diagnosis of schizophreniaschizoaffective disorder and OCD each patient will be evaluated by PANSS Y-BOCS and GCI-S scales Those patients who score above 12 points on the Y-BOCS will be eligible for the study
Rating scales PANSS Y-BOCS CGI-S CGI-I will be completed on a weekly basis during the whole 13 weeks period In addition patients will be asked to report medication side effects and will also be clinically evaluated for side effects by the physician Special attention will be paid to worsening of psychosis or OC symptoms All patients whose mental status will deteriorate or those who cannot tolerate the drug will be dropped-out and intent to treat analysis will be made
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