Treatment of Schizophrenic Patients With Ziprasidone (TRITON)

• 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.
  
  

• 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 ]
  

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

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