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

NCT00649844 | Completed Phase 3 DMC

• 1 other identifier: A1281039
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 21

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores

  Until Final Visit (within 18 weeks)

Secondary Outcomes (16)

• Proportion of responders, based on change from baseline to endpoint in PANSS total score

  Until Final Visit (within 18 weeks)

• Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores

  Baseline and weekly from Weeks 1-18

• Time to discontinuation

  Up to 18 weeks

• Change from baseline to endpoint in cognitive function assessments, including Rey serial verbal learning test, Stroop Color Word test, and Trail Making Test

  Baseline and Weeks 12 and 18

• Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores

  Baseline and Week 8, 12, and 18

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Clozapine

B

EXPERIMENTAL

Drug: Ziprasidone

Interventions

Clozapine DRUG

Clozapine 25 or 100 mg tablets. Patients were initially titrated over the first 10 days to 300 mg/day and remained at this dose for 1 week. Thereafter, the dose could be varied between 250 and 600 mg/day based on response and tolerability for a total treatment duration of 18 weeks

A

Ziprasidone DRUG

Ziprasidone 40, 60, or 80 mg capsules. Patients were initially titrated over the first 3 days to 80 mg/day, which could subsequently be increased to between 80 and 160 mg/day based on response and tolerability for a total treatment duration of 18 weeks

Also known as: Geodon, Zeldox

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (22)

Pfizer Investigational Site

Città di Castello, Perugia, 06012, Italy

Location

Pfizer Investigational Site

Bassano del Grappa, Vicenza, 36061, Italy

Location

Pfizer Investigational Site

Bari, 70124, Italy

Location

Pfizer Investigational Site

Brescia, 25100, Italy

Location

Pfizer Investigational Site

Cagliari, 09045, Italy

Location

Pfizer Investigational Site

Cagliari, 09124, Italy

Location

Pfizer Investigational Site

Catania, 95123, Italy

Location

Pfizer Investigational Site

Florence, 50134, Italy

Location

Pfizer Investigational Site

Guardiagrele (CH), 66016, Italy

Location

Pfizer Investigational Site

Messina, 98100, Italy

Location

Pfizer Investigational Site

Montichiari (brescia), 25018, Italy

Location

Pfizer Investigational Site

Napoli, 80131, Italy

Location

Pfizer Investigational Site

Parma, 43100, Italy

Location

Pfizer Investigational Site

Reggio Calabria, 89100, Italy

Location

Pfizer Investigational Site

Roma, 00135, Italy

Location

Pfizer Investigational Site

Roma, 00137, Italy

Location

Pfizer Investigational Site

Sassari, 07100, Italy

Location

Pfizer Investigational Site

Siena, 53100, Italy

Location

Pfizer Investigational Site

Torino, 10126, Italy

Location

Pfizer Investigational Site

Trieste, 34126, Italy

Location

Pfizer Investigational Site

Verona, 37126, Italy

Location

Pfizer Investigational Site

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Schizophrenia

Interventions

Clozapine; ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 1, 2008
• Study Start: January 1, 2003
• Study Completion: September 1, 2004
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

IT (21)