NCT00229385

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

Enrollment Period

2.2 years

First QC Date

September 28, 2005

Last Update Submit

December 30, 2013

Conditions

SchizophreniaObsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • YBOCS

    8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Ziprasidone

2

ACTIVE COMPARATOR
Drug: Ziprasidone

Interventions

ZiprasidoneDRUG

40-80 mg BID

12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

SchizophreniaObsessive-Compulsive Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersAnxiety Disorders

Study Officials

  • Joseph Zohar, MD

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Joseph Zohar

Study Record Dates

First Submitted

September 28, 2005

First Posted

September 29, 2005

Study Start

January 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2010

Last Updated

December 31, 2013

Record last verified: 2013-12

Locations

IL(1)