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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.89 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia Mania Delusional Disorder Acute Exacerbation of Psychosis

Interventions

ZiprasidoneDRUG

Intramuscular ziprasidone 10 or 20 mg at the investigator's discretion for 1 to 3 days followed by oral ziprasidone capsules 40 to 80 mg twice daily at the investigator's discretion to complete 7 days of treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (8)

Pfizer Investigational Site

Fortaleza, Ceará, Brazil

Pfizer Investigational Site

Salvador, Estado de Bahia, Brazil

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, Brazil

Pfizer Investigational Site

Curitiba, Paraná, Brazil

Outcomes

Primary Outcomes

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

Time frame: Days 1-3 (end of intramuscular dosing)

Secondary Outcomes

Electrocardiogram at Visits 1 and 5

Time frame: Visits 1 (Screening) and 5 (Day 7)

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

Time frame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)

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

Time frame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4) and 5 (Day 7)

Laboratory tests at Visits 1 and 5

Time frame: Visits 1 (Screening) and 5 (Day 7)

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

Time frame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)

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

Time frame: Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)

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

Time frame: Visits 1 (Screening), 2 (Day 1), and 5 (Day 7)

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

Time frame: Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)

Data from ClinicalTrials.gov

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