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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
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 28, 2005
Last Updated
December 30, 2013
Sponsor
Sheba Medical Center
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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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