Treatment of Schizophrenic Patients With Ziprasidone (TRITON)

February 18, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment of Schizophrenic Patients With Geodon; Capsules/Oral Suspension/Solution for Injection (Ziprasidone)

To determine whether ziprasidone provides good efficacy and tolerability in the treatment of schizophrenic Greek patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sampling Method Details: Non-interventional study (subjects chosen by physician in accordance to their usual practice).

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 12461
        • Pfizer Investigational Site
      • Chaidari, Greece, 124 61
        • Pfizer Investigational Site
      • Chaidari, Greece, 12461
        • Pfizer Investigational Site
      • Chaidari, Greece, 12462
        • Pfizer Investigational Site
      • Corfu, Greece, 49100
        • Pfizer Investigational Site
      • Crete, Greece, 731-00
        • Pfizer Investigational Site
      • Giannitsa, Greece, 58100
        • Pfizer Investigational Site
      • Haidari, Greece, 12461
        • Pfizer Investigational Site
      • Kalamata, Greece, 24100
        • Pfizer Investigational Site
      • Katerini, Greece, 60100
        • Pfizer Investigational Site
      • Kozani, Greece, 50100
        • Pfizer Investigational Site
      • Kozani, Greece
        • Pfizer Investigational Site
      • Lamia, Greece, 35100
        • Pfizer Investigational Site
      • Larisa, Greece
        • Pfizer Investigational Site
      • Patra, Greece, 26000
        • Pfizer Investigational Site
      • Patra, Greece, 26001
        • Pfizer Investigational Site
      • Thessaloniki, Greece, 57010
        • Pfizer Investigational Site
      • Thessaloniki, Greece, 564-29
        • Pfizer Investigational Site
      • Thessaloniki, Greece, 56430
        • Pfizer Investigational Site
      • Volos, Greece, 38222
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with schizophrenia

Description

Inclusion Criteria:

  • Usual clinical practice of physician

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of Schizophrenia
Time Frame: Baseline
Stage, symptoms and type of schizophrenia were recorded in addition to demographic and other clinical history data at the Baseline visit. The primary outcome was to assess the participants profile. Some assessments have been included in the Baseline demographics. This outcome presents results for the Summary of Schizophrenia.
Baseline
Summary of Metabolic Risk Factors
Time Frame: Baseline
Baseline
Summary of Most Frequently Used Concomitant Drug Treatments
Time Frame: Baseline
Most frequently concomitant drug treatments used by >15 participants.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Time Frame: Week 12
CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Week 12
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Time Frame: Baseline, Week 12
CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)
Baseline, Week 12
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Time Frame: Baseline, Week 12
Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.
Baseline, Week 12
PANSS - Negative Subscale
Time Frame: Baseline, Week 12
Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.
Baseline, Week 12
PANSS - Composite Subscale
Time Frame: Baseline, Week 12
The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.
Baseline, 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
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
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
Week 12
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
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
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
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
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
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
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
Week 12
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?"
Time Frame: Week 12
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
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
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
Week 12
Percent Change From Baseline to Final Visit in Body Weight
Time Frame: Baseline, Week 12
Baseline, Week 12

Other Outcome Measures

Outcome Measure
Time Frame
Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 24, 2007

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1281156

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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