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

Phase 4

Completed

• Conditions: Mania; Schizophrenia; Delusional Disorder; Acute Exacerbation of Psychosis
• Interventions: Drug: Ziprasidone

• Registration Number: NCT00644800
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study Completion: 2004-05
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	Ziprasidone	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores	Days 1-3 (end of intramuscular dosing)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Patient Preference Scale (PPS) scores at Visits 3 and 5	Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4) and 5 (Day 7)
Adverse events at Visits 2, 3, 4, and 5	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	Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)
Electrocardiogram at Visits 1 and 5	Visits 1 (Screening) and 5 (Day 7)
Laboratory tests at Visits 1 and 5	Visits 1 (Screening) and 5 (Day 7)
Change from baseline in Clinical Global Impression-Severity (CGI-S) scores at Visits 3, 4, and 5	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	Visits 1 (Screening), 2 (Day 1), and 5 (Day 7)
Movement disorder rating scale scores (Barnes Akathisia Scale and Extrapyramidal Symptoms Rating Scale) at Visits 2, 3, 4, and 5	Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇷 Sao Paulo, SP, Brazil