Clinical trial NCT00649844: A Study Comparing the Efficacy and Tolerability of Ziprasidone vs. Clozapine for the Treatment of Schizophrenia in Patients Who Continue to Have Symptoms on or Cannot Tolerate Other Antipsychotic Drugs
Official title: Double Blind, Double-Dummy Multicenter, Parallel Group Comparison Of The Efficacy And The Tolerability Of Ziprasidone Vs. Clozapine In Schizophrenic Patients Who Are Refractory And/Or Intolerant To Antipsychotic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of ziprasidone and clozapine in schizophrenic patients who are resistant and/or intolerant to antipsychotic treatment


Eligibility criteria: Inclusion Criteria:

* CGI - S ≥4
* PANSS ≥ 80
* Inpatients or outpatients

Exclusion Criteria:

* Patients with a history of myeloproliferative diseases, history of granulocytopenia, agranulocytosis due to a drug
* Diagnosis of substance dependence within previous 3 months using DSM-IV criteria
* History of seizure
* Organic mental disease, including mental retardation or epilepsy

Primary outcomes:
measure: Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores
timeFrame: Until Final Visit (within 18 weeks)
Secondary outcomes:
measure: Proportion of responders, based on change from baseline to endpoint in PANSS total score
timeFrame: Until Final Visit (within 18 weeks)
measure: Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores
timeFrame: Baseline and weekly from Weeks 1-18
measure: Time to discontinuation
timeFrame: Up to 18 weeks
measure: Change from baseline to endpoint in cognitive function assessments, including Rey serial verbal learning test, Stroop Color Word test, and Trail Making Test
timeFrame: Baseline and Weeks 12 and 18
measure: Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores
timeFrame: Baseline and Week 8, 12, and 18
measure: Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores
timeFrame: Baseline and Weeks 4, 8, 12, and 18
measure: Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores
timeFrame: Screening and Weeks 1, 8, 12, and 18
measure: Change from baseline to endpoint in PANSS subscale scores
timeFrame: Baseline and weekly from Weeks 1-18
measure: Adverse events
timeFrame: Weekly from Weeks 1-18
measure: Change from baseline to endpoint in Calgary Depression Scale (CDSS) scores
timeFrame: Baseline and Weeks 8, 12, and 18
measure: Change from baseline in Caregiver Activity Survey (CAS)
timeFrame: Screening and Weeks 1, 8, 12, and 18
measure: Change from baseline in laboratory tests
timeFrame: Screening and weekly from Weeks 1-18
measure: Change from baseline in electrocardiogram
timeFrame: Screening and Weeks 1, 8, 12, and 18
measure: Change from baseline in movement disorder rating scales, including Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale, and Simpson-Angus Scale
timeFrame: Baseline and Weeks 1, 8, 12, and 18
measure: Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scores
timeFrame: Baseline and weekly from Weeks 1-18
measure: Change from baseline to endpoint in Patient Preference Scale (PPS) scores
timeFrame: Screening and Weeks 1, 8, 12, and 18
Other outcomes:
Locations:
city: Citta' Di Castello
country: Italy
facility: Pfizer Investigational Site
state: Perugia
city: Bassano Del Grappa
country: Italy
facility: Pfizer Investigational Site
state: Vicenza
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Brescia
country: Italy
facility: Pfizer Investigational Site
city: Cagliari
country: Italy
facility: Pfizer Investigational Site
city: Cagliari
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Guardiagrele (CH)
country: Italy
facility: Pfizer Investigational Site
city: Messina
country: Italy
facility: Pfizer Investigational Site
city: Montichiari (brescia)
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Parma
country: Italy
facility: Pfizer Investigational Site
city: Reggio Calabria
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Sassari
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Trieste
country: Italy
facility: Pfizer Investigational Site
city: Verona
country: Italy
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: