Clinical trial NCT00708396: Tolerability And Efficacy Of High Dose Escitalopram In The Treatment Of Patients Suffering From Schizophrenia And Obsessive-Compulsive Disorder (OCD) - An Open Label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: OCD
Schizophrenia
Keywords: Patients
suffer
from
Lead sponsor: BeerYaakov Mental Health Center
Sponsor class: OTHER_GOV
First posted: 2008-07-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Symptom Checklist
timeFrame: on a weekly basis during the whole 13 weeks period
measure: 2. Positive and negative symptoms scale ( PANSS)
timeFrame: on a weekly basis during the whole 13 weeks period
measure: 3. The Clinical Global Impression scales (CGI) consist of two sub-scales: The Severity of illness (CGI-S) and the Global improvement (CGI-I).
timeFrame: on a weekly basis during the whole 13 weeks period
measure: 4. Blood lipids and blood glucose prior to escitalopram up-titration over 20mg/d and at last visit
timeFrame: on a weekly basis during the whole 13 weeks period
measure: 5. EKG and physical examination will be performed at baseline 6. AE checklist at every visit 7. Recent and concomitant medications at every visit
timeFrame: on a weekly basis during the whole 13 weeks period
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Yaacov
country: Israel
facility: Beer-Yaacov MHC
Study officials:
affiliation: Beer-Yaacov MHC
name: Rafael Octavio Stryjer, MD
role: PRINCIPAL_INVESTIGATOR
References: