Treatment of Schizophrenic Patients With Ziprasidone (TRITON)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00579670
First received: December 20, 2007
Last updated: September 16, 2010
Last verified: September 2010
  Purpose

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


Condition Intervention
Schizophrenia
Drug: Ziprasidone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Schizophrenic Patients With Geodon; Capsules/Oral Suspension/Solution for Injection (Ziprasidone)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Summary of Schizophrenia [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Summary of Metabolic Risk Factors [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Summary of Most Frequently Used Concomitant Drug Treatments [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Most frequently concomitant drug treatments used by >15 participants.


Secondary Outcome Measures:
  • Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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)

  • Positive and Negative Syndrome Scale (PANSS) - Positive Subscale [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.

  • PANSS - Negative Subscale [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.

  • PANSS - Composite Subscale [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?" [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?" [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?" [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?" [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?" [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?" [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline to Final Visit in Body Weight [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: Yes ]

Enrollment: 450
Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579670

Locations
Greece
Pfizer Investigational Site
Athens, Greece, 12461
Pfizer Investigational Site
Chaidari, Greece, 12462
Pfizer Investigational Site
Chaidari, Greece, 124 61
Pfizer Investigational Site
Chaidari, Greece, 12461
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, 56430
Pfizer Investigational Site
Thessaloniki, Greece, 564-29
Pfizer Investigational Site
Volos, Greece, 38222
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00579670     History of Changes
Other Study ID Numbers: A1281156
Study First Received: December 20, 2007
Results First Received: April 2, 2010
Last Updated: September 16, 2010
Health Authority: Greece: National Organization of Medicines

Keywords provided by Pfizer:
Ziprasidone in patients with schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 18, 2014