A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis

Condition(s) targeted: Schizophrenia; Mania; Delusional Disorder; Acute Exacerbation of Psychosis

Intervention: Ziprasidone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the treatment of the acute exacerbation of non-organic psychosis of any etiology, including schizophrenia, acute mania, delusional disorder and others.

Official title: An Open, Multicenter, Non-Comparative Study To Assess The Efficacy And Tolerability Of Intramuscular Ziprasidone Followed By Oral Ziprasidone In Patients With Acute Psychosis

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores

Secondary outcome:

Electrocardiogram at Visits 1 and 5

Adverse events at Visits 2, 3, 4, and 5

Change from baseline in Patient Preference Scale (PPS) scores at Visits 3 and 5

Laboratory tests at Visits 1 and 5

Movement disorder rating scale scores (Barnes Akathisia Scale and Extrapyramidal Symptoms Rating Scale) at Visits 2, 3, 4, and 5

Change from baseline in PANSS excitation items scores at Visits 3, 4, and 5

Blood pressure and pulse at Visits 1, 2, and 5

Change from baseline in Clinical Global Impression-Severity (CGI-S) scores at Visits 3, 4, and 5

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Hospitalized patients with psychosis

- Eligible for intramuscular treatment

- Miminum score of 60 on the PANSS, a score of 14 in the sum of PANSS excitation score

and a score of at least 4 in 1 of the following items: poor control of impulses, tension, hostility, uncooperativeness or excitation.

Exclusion Criteria:

- Treatment with antidepressants or mood stabilizers within seven days prior to the

enrollment; for monoamine oxidase inhibitors (MAOIs) and moclobemide, this period must be two weeks; for fluoxetine, five weeks

- Resistance to conventional antipsychotic agents

- A history of epilepsy

- A diagnosis of abuse of substance within the previous 3 months according to the DSMIV

criteria.

Pfizer Investigational Site, SALVADOR, BAHIA 41180-000, Brazil

Pfizer Investigational Site, FORTALEZA, CEARA 60175-270, Brazil

Pfizer Investigational Site, Curitiba, PR, Brazil

Pfizer Investigational Site, RIO DE JANEIRO, RJ, Brazil

Pfizer Investigational Site, SAO GONCALO, RJ, Brazil

Pfizer Investigational Site, SAO PAULO, SP, Brazil

Pfizer Investigational Site, JARDIM SANTA MONICA SN, Salvador - Ba 40340-720, Brazil

Pfizer Investigational Site, BELO HORIZONTE, mg 30150-270, Brazil

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

Link to ClinicalStudyResults.org Posting

Starting date: July 2003
Ending date: May 2004
Last updated: April 7, 2008