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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00579670
Date of registration: 20/12/2007
Primary sponsor: Pfizer
Public title: Treatment of Schizophrenic Patients With Ziprasidone TRITON
Scientific title: Treatment of Schizophrenic Patients With Geodon; Capsules/Oral Suspension/Solution for Injection (Ziprasidone)
Date of first enrolment: October 2007
Target sample size: 450
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00579670
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Countries of recruitment
Greece
Contacts
Name:   Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
Affiliation:  Pfizer
Key inclusion & exclusion criteria

Inclusion Criteria:

- Usual clinical practice of physician

Exclusion Criteria:

- None



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Schizophrenia
Intervention(s)
Drug: Ziprasidone
Primary Outcome(s)
Summary of Metabolic Risk Factors [Time Frame: Baseline]
Summary of Most Frequently Used Concomitant Drug Treatments [Time Frame: Baseline]
Summary of Schizophrenia [Time Frame: Baseline]
Secondary Outcome(s)
Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?" [Time Frame: Week 12]
Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?" [Time Frame: Week 12]
Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?" [Time Frame: Week 12]
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?" [Time Frame: Week 12]
Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?" [Time Frame: Week 12]
Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?" [Time Frame: Week 12]
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?" [Time Frame: Week 12]
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?" [Time Frame: Week 12]
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?" [Time Frame: Week 12]
Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?" [Time Frame: Week 12]
Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?" [Time Frame: Week 12]
Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?" [Time Frame: Week 12]
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?" [Time Frame: Week 12]
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?" [Time Frame: Week 12]
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) [Time Frame: Week 12]
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) [Time Frame: Baseline, Week 12]
PANSS - Composite Subscale [Time Frame: Baseline, Week 12]
PANSS - Negative Subscale [Time Frame: Baseline, Week 12]
Percent Change From Baseline to Final Visit in Body Weight [Time Frame: Baseline, Week 12]
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale [Time Frame: Baseline, Week 12]
Secondary ID(s)
A1281156
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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