Treatment of Schizophrenic Patients With Ziprasidone

Completed

Conditions: Schizophrenia

Registration Number: NCT00579670

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

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

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 450

Inclusion Criteria

Usual clinical practice of physician

Exclusion Criteria

None

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Summary of Schizophrenia	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.
Summary of Metabolic Risk Factors	Baseline
Summary of Most Frequently Used Concomitant Drug Treatments	Baseline	Most frequently concomitant drug treatments used by \>15 participants.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)	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.
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)	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)
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale	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.
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
Percent Change From Baseline to Final Visit in Body Weight	Baseline, Week 12
PANSS - Negative Subscale	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.
PANSS - Composite Subscale	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.
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 "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