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Treatment of Schizophrenic Patients With Ziprasidone (TRITON)

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ClinicalTrials.gov Identifier: NCT00579670
Recruitment Status : Completed
First Posted : December 24, 2007
Results First Posted : May 17, 2010
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description
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Brief Summary:
To determine whether ziprasidone provides good efficacy and tolerability in the treatment of schizophrenic Greek patients.

Condition or disease Intervention/treatment
Schizophrenia Drug: Ziprasidone

Detailed Description:
Sampling Method Details: Non-interventional study (subjects chosen by physician in accordance to their usual practice).
Study Design
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Study Type : Observational
Actual Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Schizophrenic Patients With Geodon; Capsules/Oral Suspension/Solution for Injection (Ziprasidone)
Study Start Date : October 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Groups and Cohorts
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Intervention Details:
  • Drug: Ziprasidone
    Ziprasidone 20mg, 40mg, 60mg, 80mg capsules, hard; Ziprasidone 10 mg/ml oral suspension Ziprasidone 20mg/ml powder and solvent for the reconstitution of solution for injection
    Other Name: Geodon, Zeldox

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Summary of Metabolic Risk Factors [ Time Frame: Baseline ]
  3. Summary of Most Frequently Used Concomitant Drug Treatments [ Time Frame: Baseline ]
    Most frequently concomitant drug treatments used by >15 participants.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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 ]
  7. Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?" [ Time Frame: Week 12 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  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 ]
  13. Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?" [ Time Frame: Week 12 ]
  14. Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?" [ Time Frame: Week 12 ]
  15. 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 ]
  16. Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?" [ Time Frame: Week 12 ]
  17. Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?" [ Time Frame: Week 12 ]
  18. 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 ]
  19. Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?" [ Time Frame: Week 12 ]
  20. Percent Change From Baseline to Final Visit in Body Weight [ Time Frame: Baseline, Week 12 ]

Other Outcome Measures:
  1. Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period [ Time Frame: Week 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with schizophrenia
Criteria

Inclusion Criteria:

  • Usual clinical practice of physician

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579670


Locations
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Greece
Pfizer Investigational Site
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, 564-29
Pfizer Investigational Site
Thessaloniki, Greece, 56430
Pfizer Investigational Site
Thessaloniki, Greece, 57010
Pfizer Investigational Site
Volos, Greece, 38222
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00579670    
Other Study ID Numbers: A1281156
First Posted: December 24, 2007    Key Record Dates
Results First Posted: May 17, 2010
Last Update Posted: March 10, 2021
Last Verified: February 2021
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Ziprasidone in patients with schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents