Clinical trial NCT00579670: Treatment of Schizophrenic Patients With Ziprasidone
Official title: Treatment of Schizophrenic Patients With Geodon; Capsules/Oral Suspension/Solution for Injection (Ziprasidone)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Ziprasidone in patients with schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-24
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with schizophrenia

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).

Eligibility criteria: Inclusion Criteria:

* Usual clinical practice of physician

Exclusion Criteria:

* None

Primary outcomes:
measure: Summary of Schizophrenia
timeFrame: Baseline
measure: Summary of Metabolic Risk Factors
timeFrame: Baseline
measure: Summary of Most Frequently Used Concomitant Drug Treatments
timeFrame: Baseline
Secondary outcomes:
measure: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
timeFrame: Week 12
measure: Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
timeFrame: Baseline, Week 12
measure: Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
timeFrame: Baseline, Week 12
measure: PANSS - Negative Subscale
timeFrame: Baseline, Week 12
measure: PANSS - Composite Subscale
timeFrame: Baseline, Week 12
measure: Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?"
timeFrame: Week 12
measure: Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?"
timeFrame: Week 12
measure: Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?"
timeFrame: Week 12
measure: Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?"
timeFrame: Week 12
measure: Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?"
timeFrame: Week 12
measure: 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)?"
timeFrame: Week 12
measure: 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)?"
timeFrame: Week 12
measure: Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?"
timeFrame: Week 12
measure: Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?"
timeFrame: Week 12
measure: Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?"
timeFrame: Week 12
measure: Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?"
timeFrame: Week 12
measure: Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?"
timeFrame: Week 12
measure: Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?"
timeFrame: Week 12
measure: Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?"
timeFrame: Week 12
measure: Percent Change From Baseline to Final Visit in Body Weight
timeFrame: Baseline, Week 12
Other outcomes:
measure: Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period
timeFrame: Week 12
Locations:
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Chaidari
country: Greece
facility: Pfizer Investigational Site
city: Chaidari
country: Greece
facility: Pfizer Investigational Site
city: Chaidari
country: Greece
facility: Pfizer Investigational Site
city: Corfu
country: Greece
facility: Pfizer Investigational Site
city: Crete
country: Greece
facility: Pfizer Investigational Site
city: Giannitsa
country: Greece
facility: Pfizer Investigational Site
city: Haidari
country: Greece
facility: Pfizer Investigational Site
city: Kalamata
country: Greece
facility: Pfizer Investigational Site
city: Katerini
country: Greece
facility: Pfizer Investigational Site
city: Kozani
country: Greece
facility: Pfizer Investigational Site
city: Kozani
country: Greece
facility: Pfizer Investigational Site
city: Lamia
country: Greece
facility: Pfizer Investigational Site
city: Larisa
country: Greece
facility: Pfizer Investigational Site
city: Patra
country: Greece
facility: Pfizer Investigational Site
city: Patra
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Volos
country: Greece
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: