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
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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 4 |
| Study Type: | Interventional |
| 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 ]
| 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).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | Recruiting |
| Beer-Yaacov, Israel, 70350 | |
| Contact: Rafael O Stryjer, MD 972-8-9258396 research@beerness.health.gov.il | |
| 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 May 21, 2013