NCT00708396|UnknownPhase 4DMC
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Sponsor study identifier
interventional
20
1 country
1
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of the study is to evaluate tolerability and efficacy of escitalopram (Cipralex) treatment in doses beyond 20mg (20-40 mg/d) 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 schizophrenia/schizoaffective 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 1, 2008
Actual (reported)July 2, 2008
Actual (reported)July 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Symptom Checklist
on a weekly basis during the whole 13 weeks period
2. Positive and negative symptoms scale ( PANSS)
on a weekly basis during the whole 13 weeks period
3. The Clinical Global Impression scales (CGI) consist of two sub-scales: The Severity of illness (CGI-S) and the Global improvement (CGI-I).
on a weekly basis during the whole 13 weeks period
4. Blood lipids and blood glucose prior to escitalopram up-titration over 20mg/d and at last visit
on a weekly basis during the whole 13 weeks period
5. EKG and physical examination will be performed at baseline 6. AE checklist at every visit 7. Recent and concomitant medications at every visit
on a weekly basis during the whole 13 weeks period
Patients which diagnosed as OCD and schizophrenia
First week; 10mg/d of Escitalopram Weeks 2-5; 20mg/d of Escitalopram After 4 weeks of 20mg treatment (2-5 weeks of the study) - if partial/no response according to YBOCS score and clinical judgment, the dose will be increased up to 30mg for 4 weeks (weeks 6-9) and in case of partial/ non response the dose will be increased up to 40 mg until the completion of the study (weeks 10-13).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Beer-Yaacov MHC
Beer-Yaacov, 70350, Israel
Rafael Octavio Stryjer, MD
Beer-Yaacov MHC
First Submitted
July 1, 2008
First Posted
July 2, 2008
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Estimated (date passed)Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 27, 2009
Record last verified: 2009-01
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Source: ClinicalTrials.gov.
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