Treatment of Schizophrenic Patients With Ziprasidone

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

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

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Ziprasidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Usual clinical practice of physician Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Schizophrenia | 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 |  | Baseline | 
| Summary of Most Frequently Used Concomitant Drug Treatments | 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) | 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) | 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 | 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 | 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 | 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? |  | Week 12 | 
| Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms? |  | 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? |  | Week 12 | 
| Number of Participants Answering the Question As a Result of Taking This Medication, do You Experience Any Side Effects at All? |  | Week 12 | 
| Number of Participants Answering the Question How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition? |  | 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)? |  | 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)? |  | Week 12 | 
| Number of Participants Answering the Question To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication? |  | Week 12 | 
| Number of Participants Answering the Question How Easy or Difficult is it to Use the Medication in Its Current Form? |  | Week 12 | 
| Number of Participants Answering the Question How Easy or Difficult is it to Plan When You Will Use the Medication Each Time? |  | Week 12 | 
| Number of Participants Answering the Question How Convenient or Inconvenient is it to Take the Medication as Instructed? |  | Week 12 | 
| Number of Participants Answering the Question Overall, How Confident Are You That Taking This Medication is a Good Thing? |  | Week 12 | 
| Number of Participants Answering the Question How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things? |  | Week 12 | 
| Number of Participants Answering the Question Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication? |  | Week 12 | 
| Percent Change From Baseline to Final Visit in Body Weight |  | Baseline, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ziprasidone in patients with schizophrenia