Pyschotic Disorders Clinical Trial
Official title:
An Open Label, Extension Study To Assess The Efficacy And Tolerability Of Oral Ziprasidone In Patients Successfully Completing A Previous Study With Ziprasidone
| NCT number | NCT00645320 |
| Other study ID # | A1281114 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | August 2003 |
| Est. completion date | August 2004 |
| Verified date | February 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy and tolerability of ziprasidone in patients who successfully completed a study of ziprasidone treatment of psychosis (Protocol A1281074).
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | August 2004 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | Inclusion Criteria: - Psychotic disorder - Completion of previous study of intramuscular ziprasidone - Ability to continue with oral ziprasidone Exclusion Criteria: - Concomitant treatment with other anti-psychotic agents within 12 hours prior to the enrollment; for depot agents, a period of two weeks or a cycle, whichever is longer, should occur between the last administration and the patient's enrollment. - Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for MAOIs (monoamine oxidase inhibitors) and moclobemide, this period should be of two weeks; for fluoxetine, five weeks. - Resistance to conventional psychotic agents. (Resistance is defined as a failure to present a therapeutic response during the acute exacerbation after proper attempts of treatment with marketed antipsychotic agents in two or more occasions during the two years prior to the enrollment in the study.) |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Pfizer Investigational Site | Belo Horizonte | MG |
| Brazil | Pfizer Investigational Site | Curitiba | PR |
| Brazil | Pfizer Investigational Site | Fortaleza | Ceara |
| Brazil | Pfizer Investigational Site | Jardim Santa Monica SN | Salvador - BA |
| Brazil | Pfizer Investigational Site | Rio de Janeiro | RJ |
| Brazil | Pfizer Investigational Site | RIO DE Janeiro RJ | |
| Brazil | Pfizer Investigational Site | Salvador | Bahia |
| Brazil | Pfizer Investigational Site | Sao Paulo | SP |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in Clinical Global Impression-Severity (CGI-S) score | Until Final Visit (within 3 months) | ||
| Secondary | Adverse events | Baseline and Months 1, 2, and 3 |