Clinical trial NCT00645229: A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Official title: Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of ziprasidone in acute exacerbation of schizophrenia or schizoaffective disorder, including patients with recent onset of symptoms

Detailed description: The study was prematurely discontinued due to the difficulty of subject recruitment on March 24, 2005. There were no safety concerns that led to the decision to terminate.

Eligibility criteria: Inclusion Criteria:

* Patients not currently being treated with antipsychotic medication and neuroleptic naive patients
* Diagnosis of schizophrenia or schizoaffective disorder
* Antipsychotic treatment prior to screening was to be for a cumulative period of less than 5 years

Exclusion Criteria:

* Patients at immediate risk of committing harm to self or others
* Treatment with clozapine within 3 months prior to baseline
* History of neuroleptic treatment
* Current antipsychotic treatment

Primary outcomes:
measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24
timeFrame: Week 24
measure: Change from baseline in PANSS (Depression-C) score at Week 24
timeFrame: Week 24
measure: Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24
timeFrame: Week 24
measure: Change from baseline in CGI-S total score at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Vital signs and weight at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
timeFrame: Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
measure: Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24
timeFrame: Week 24
measure: Adverse events on Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
timeFrame: Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
measure: Change from baseline in Global Assessment of Functioning (GAF) score at Week 24
timeFrame: Week 24
measure: Laboratory parameters at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
timeFrame: Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
measure: Simpson-Angus Scale (SAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
timeFrame: Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
measure: Barnes Akathisia Scale (BAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
timeFrame: Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
measure: Electrocardiogram
timeFrame: Screening and Month 4
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: