- ICH GCP
- US Clinical Trials Registry
- 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
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Rafael Octavio Stryjer, MD
- Phone Number: 972-8-9258404
- Email: stryjer@gmail.com
Study Contact Backup
- Name: Igor Timinsky, MD
- Phone Number: 972-8-9258404
- Email: Igor.Timinsky@beerness.health.gov.il
Study Locations
-
-
-
Beer-Yaacov, Israel, 70350
- Recruiting
- Beer-Yaacov MHC
-
Contact:
- Rafael O Stryjer, MD
- Phone Number: 972-8-9258396
- Email: research@beerness.health.gov.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Rafael Octavio Stryjer, MD, Beer-Yaacov MHC
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- Escitalopram -199CTIL
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.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
Bradley LegaRecruiting
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingTreatment-resistant SchizophreniaUnited States
Clinical Trials on Escitalopram
-
First Affiliated Hospital of Zhejiang UniversityRecruitingAdolescent | Depressive DisorderChina
-
Perry RenshawTerminatedDepression | Substance Use | Dual DiagnosisUnited States
-
University of NebraskaRecruiting
-
Rigshospitalet, DenmarkUniversity of Cambridge; Lundbeck FoundationCompleted
-
Ryerson UniversityUnknownInsomnia | Major Depressive DisorderCanada
-
Centre Hospitalier Universitaire VaudoisNot yet recruitingPharmacogenetic Testing
-
Shanghai 7th People's HospitalNot yet recruitingDepressive Disorder, MajorChina
-
Shanghai Mental Health CenterJiangsu Nhwa Pharmaceutical Co., Ltd.Completed
-
Shanghai Mental Health CenterRecruiting
-
University of PennsylvaniaWashington University School of MedicineCompleted