Tolerability And Efficacy Of High Dose Escitalopram In The Treatment Of Patients Suffering From Schizophrenia And Obsessive-Compulsive Disorder (OCD) - An Open Label Study - Full Text View

Sponsor:	BeerYaakov Mental Health Center
Information provided by:	BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier:	NCT00708396

Purpose

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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Obsessive-Compulsive Disorder Schizophrenia

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by BeerYaakov Mental Health Center:

Primary Outcome Measures:

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 ]

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
Experimental: Patients Patients which diagnosed as OCD and schizophrenia	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).

Arms

Assigned Interventions

Experimental: Patients

Patients which diagnosed as OCD and schizophrenia

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients will be men and women over 18 years of age who meet DSM-IV criteria for schizophrenia/ schizoaffective disorder and OCD.
Previous to entering the study all patients should be stabilized on antipsychotic medication for at least 3 months.
Patients should score above 12 points on Yale Brown Obsessive Compulsive Scale (Y-BOCS) (Cut off point of Y-BOCS total score > or =7 is the common practice in similar studies) (Kayahan et al 2005).

Exclusion Criteria:

All patients who are under antidepressant treatment (including SSRIs and clomipramine).
In patients who were on clomipramine or SSRI in the past are included, at least 2 weeks must have been elapsed since stopping the medication.
In case the patient has received an antidepressant which is not an SSRI or clomipramine, there will be a washout period of one week before entering the study.
If the patient received a MAO-inhibitors there will be a washout period of at least 2 weeks except for fluoxetine for which a washout period of 5 weeks is required due to its long half-life.
Known contraindication for the use of citalopram or escitalopram.
Abnormal ECG findings at baseline
Unable to understand and give informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708396

Contacts

Contact: Rafael Octavio Stryjer, MD	972-8-9258404	stryjer@gmail.com
Contact: Igor Timinsky, MD	972-8-9258404	Igor.Timinsky@beerness.health.gov.il

Locations

Israel
Beer-Yaacov MHC	Recruiting
Beer-Yaacov, Israel, 70350
Contact: Rafael O Stryjer, MD 972-8-9258396 research@beerness.health.gov.il

Sponsors and Collaborators

BeerYaakov Mental Health Center

Investigators

Principal Investigator:

Rafael Octavio Stryjer, MD

Beer-Yaacov MHC

More Information

No publications provided

Responsible Party:	BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier:	NCT00708396 History of Changes
Other Study ID Numbers:	Escitalopram -199CTIL
Study First Received:	July 1, 2008
Last Updated:	January 26, 2009
Health Authority:	Israel: Ministry of Health

Keywords provided by BeerYaakov Mental Health Center:

Patients
suffer
from

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder
Schizophrenia
Anxiety Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 12, 2012