Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD)
Primary Purpose
Schizophrenia, Obsessive Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ziprasidone
Sponsored by
About this trial
This is an interventional diagnostic trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria: Diagnosis of Schizophrenia and OCD for at least 6 months Minimum score of 14 on YBOCS Minimum score of 60 on PANSS Diagnosis of Schizophrenia without OC symptoms Exclusion Criteria: Patients who are already being treated with ziprasidone Diagnosis of schizophreniform disorder Organic brain syndrome, mental retardation and pervasive developmental disorder Patients having any significantly cardiovascular illness or electrolyte imbalance
Sites / Locations
- Chaim Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
YBOCS
Secondary Outcome Measures
Full Information
NCT ID
NCT00229385
First Posted
September 28, 2005
Last Updated
December 30, 2013
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00229385
Brief Title
Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD)
Official Title
Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparing schizophrenic patients with comorbid OCD and schizophrenic patients without OCD in response to Ziprasidone and in cognitive functioning as compared with OCD patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Obsessive Compulsive Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Intervention Description
40-80 mg BID
Primary Outcome Measure Information:
Title
YBOCS
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Schizophrenia and OCD for at least 6 months
Minimum score of 14 on YBOCS
Minimum score of 60 on PANSS
Diagnosis of Schizophrenia without OC symptoms
Exclusion Criteria:
Patients who are already being treated with ziprasidone
Diagnosis of schizophreniform disorder
Organic brain syndrome, mental retardation and pervasive developmental disorder
Patients having any significantly cardiovascular illness or electrolyte imbalance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Zohar, MD
Organizational Affiliation
Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD)
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