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Sponsored by: |
BeerYaakov Mental Health Center |
Information provided by: | BeerYaakov Mental Health Center |
ClinicalTrials.gov Identifier: | NCT00708396 |
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.
Condition | Intervention | Phase |
OCD Schizophrenia |
Drug: Escitalopram |
Phase IV |
MedlinePlus related topics: | Obsessive-Compulsive Disorder Schizophrenia |
Drug Information available for: | Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 20 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Patients: Experimental
Patients which diagnosed as OCD and schizophrenia
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Drug: Escitalopram
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).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rafael Octavio Stryjer, MD | 972-8-9258404 | stryjer@gmail.com |
Contact: Igor Timinsky, MD | 972-8-9258404 | Igor.Timinsky@beerness.health.gov.il |
Israel | |||||
Beer-Yaacov MHC | |||||
Beer-Yaacov, Israel, 70350 |
BeerYaakov Mental Health Center |
Principal Investigator: | Rafael Octavio Stryjer, MD | Beer-Yaacov MHC |
Responsible Party: | BeerYaakov Mental Health Center ( BeerYaakov Mental Health Center ) |
Study ID Numbers: | Escitalopram -199CTIL |
First Received: | July 1, 2008 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00708396 |
Health Authority: | Israel: Ministry of Health |
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