12 Week Open, Non-Comparative Switch Study Of Oral Ziprazidone In Previously Treated Schizophrenic Patients

NCT00159757 | Terminated Phase 4

• 1 other identifier: A1281122
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 8

Brief Summary

There has been evidence that ziprasidone is efficacious in decreasing the magnitude of both positive and negative symptoms of schizophrenia, and also effective in the treatment of depressive symptoms. It shows good tolerance with low incidence of extrapyramidal side effects and does not significantly influence body weight. As it has been shown that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy. The purpose of the study was to provide further evidence for the efficacy and safety of patients with schizophrenia and allow for psychiatrists in Hungary to gain experience with the drug before wide commercial availability.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Efficacy- To assess the syndromes of the psychosis expressed as the PANSS total score

• Safety- Incidence and severity of the side effects

Secondary Outcomes (4)

• To assess the change of the clinical impression in CGI (Clinical Global Impression of Change scale)

• To evaluate the influence on the body weight change.

• To assess the subject's view on the treatment with ziprasidone

• To assess the subject's antidepressive efficacy by Calgary and Hamilton depression scales

Interventions

ziprazidone DRUG

Eligibility Criteria

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

You may qualify if:

• confirmed diagnosis of schizophrenia according to DSM-IV-IV from patient's medical files
• subjects with current treatment with typical or atypical neuroleptics which should be changed

You may not qualify if:

• patients with significant cardiovascular illness (recent acute myocardial infarction, uncompensated heart failure, cardiac arrhythmia)
• in the patients' history clinically significant ECG abnormalities particularly prolongation of QT interval of more than 500 ms

Sponsors & Collaborators

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

Study Sites (8)

Pfizer Investigational Site

Budapest, Hungary

Location

Pfizer Investigational Site

Debrecen, Hungary

Location

Pfizer Investigational Site

Esztergom, Hungary

Location

Pfizer Investigational Site

Kecskemét, Hungary

Location

Pfizer Investigational Site

Kistarcsa, Hungary

Location

Pfizer Investigational Site

Pécs, Hungary

Location

Pfizer Investigational Site

Székesfehérvár, Hungary

Location

Pfizer Investigational Site

Tatabánya, Hungary

Location

Related Links

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

MeSH Terms

Conditions

Schizophrenia

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: November 1, 2003
• Study Completion: February 1, 2005
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

HU (8)