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

January 26, 2009 updated by: BeerYaakov Mental Health Center

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rafael Octavio Stryjer, MD
  • Phone Number: 972-8-9258404
  • Email: stryjer@gmail.com

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Symptom Checklist
Time Frame: on a weekly basis during the whole 13 weeks period
on a weekly basis during the whole 13 weeks period
2. Positive and negative symptoms scale ( PANSS)
Time Frame: on a weekly basis during the whole 13 weeks period
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).
Time Frame: on a weekly basis during the whole 13 weeks period
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
Time Frame: on a weekly basis during the whole 13 weeks period
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
Time Frame: on a weekly basis during the whole 13 weeks period
on a weekly basis during the whole 13 weeks period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rafael Octavio Stryjer, MD, Beer-Yaacov MHC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ANTICIPATED)

July 1, 2010

Study Completion (ANTICIPATED)

July 1, 2010

Study Registration Dates

First Submitted

July 1, 2008

First Submitted That Met QC Criteria

July 1, 2008

First Posted (ESTIMATE)

July 2, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 27, 2009

Last Update Submitted That Met QC Criteria

January 26, 2009

Last Verified

January 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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