Tolerability And Efficacy Of High Dose Escitalopram In The Treatment Of Patients Suffering From Schizophrenia And Obsessive-Compulsive Disorder (OCD) - An Open Label Study
Recruitment status was Recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- 1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Symptom Checklist [ Time Frame: on a weekly basis during the whole 13 weeks period ] [ Designated as safety issue: No ]
- 2. Positive and negative symptoms scale ( PANSS) [ Time Frame: on a weekly basis during the whole 13 weeks period ] [ Designated as safety issue: No ]
- 3. The Clinical Global Impression scales (CGI) consist of two sub-scales: The Severity of illness (CGI-S) and the Global improvement (CGI-I). [ Time Frame: on a weekly basis during the whole 13 weeks period ] [ Designated as safety issue: No ]
- 4. Blood lipids and blood glucose prior to escitalopram up-titration over 20mg/d and at last visit [ Time Frame: on a weekly basis during the whole 13 weeks period ] [ Designated as safety issue: No ]
- 5. EKG and physical examination will be performed at baseline 6. AE checklist at every visit 7. Recent and concomitant medications at every visit [ Time Frame: on a weekly basis during the whole 13 weeks period ] [ Designated as safety issue: Yes ]
|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)|
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).
|Contact: Rafael Octavio Stryjer, MDfirstname.lastname@example.org|
|Contact: Igor Timinsky, MD||972-8-9258404||Igor.Timinsky@beerness.health.gov.il|
|Beer-Yaacov, Israel, 70350|
|Contact: Rafael O Stryjer, MD 972-8-9258396 email@example.com|
|Principal Investigator:||Rafael Octavio Stryjer, MD||Beer-Yaacov MHC|