A Study of Ziprasidone for the Treatment of Psychosis in Patients Who Had Already Had Benefits From Ziprasidone Treatment in a Previous Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2004-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Pyschotic Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Ziprasidone

Intervention Type DRUG

Oral ziprasidone tablets 40 or 80 mg twice daily with meals for 3 months. Doses were flexible based on investigator's discretion.

Interventions

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Ziprasidone

Oral ziprasidone tablets 40 or 80 mg twice daily with meals for 3 months. Doses were flexible based on investigator's discretion.

Intervention Type DRUG

Other Intervention Names

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Geodon, Zeldox

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No