Efficacy and Safety With Ziprasidone in First-episode Psychosis

NCT01157559

Last updated date
Study Location
Department of Psychiatry, Chonbuk national University Hospital
Jeonju, , , Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
First Episode Psychosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
14-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients who meet DSM-IV criteria for first episode schizophrenia, schizophreniform disorder and schizoaffective disorder

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients with previously prescribed antipsychotic medication in 2 weeks or more


- patients with substance-induced psychotic disorder, serious suicide attempt,
neurological disorder, etc.

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First Episode PsychosisEfficacy and Safety With Ziprasidone in First-episode Psychosis
NCT01157559
  1. Jeonju,
  2. Jeonju,
  3. Jeonju,
ALL GENDERS
14 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety With Ziprasidone in First-episode Psychosis
Official Title  ICMJE Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study
Brief Summary The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE First Episode Psychosis
Intervention  ICMJE Drug: Ziprasidone
8 week prospective study
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2010)
27
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who meet DSM-IV criteria for first episode schizophrenia, schizophreniform disorder and schizoaffective disorder

Exclusion Criteria:

  • Patients with previously prescribed antipsychotic medication in 2 weeks or more
  • patients with substance-induced psychotic disorder, serious suicide attempt, neurological disorder, etc.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 14 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01157559
Other Study ID Numbers  ICMJE 2006-Zeldox in FEP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Young Chul Chung/Professor of Psychiatry, Chonbuk National University Hospital, Jeonju, Korea
Study Sponsor  ICMJE Chonbuk National University Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Chonbuk National University Hospital
Verification Date January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP