Treatment With Ziprasidone for Schizophrenia Patients Wit... | NCT00229385

Studies
Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD)

NCT00229385

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Dec 31, 2013Estimated

Enrollment

45Actual

Phase

Not Applicable

Conditions

Schizophrenia
Obsessive Compulsive Disorder

Interventions

Ziprasidone

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2010Actual

First Submitted Date

Sep 28, 2005

First Submission Date that Met QC Criteria

Sep 28, 2005

First Posted Date

Sep 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2013

Last Update Posted Date

Dec 31, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: Ziprasidone
2	Active Comparator		Drug: Ziprasidone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ziprasidone	Drug	40-80 mg BID	1 2

Measure	Description	Time Frame
YBOCS		8 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph Zohar, MD	Tel Aviv University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chaim Sheba Medical Center		Ramat Gan		52621	Israel

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D009771	Obsessive-Compulsive Disorder

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D001008	Anxiety Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C092292	ziprasidone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided