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Completed

NCT Number: NCT00579670

Treatment of Schizophrenic Patients With Ziprasidone

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Athens, Greece

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Usual clinical practice of physician

Exclusion criteria

  • None

Treatment and study plan

Ziprasidone

Drug

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 names: Geodon, Zeldox

Primary outcomes

  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 outcomes

  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 outcomes

  1. Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Acronym: TRITON

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 24, 2007
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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