Clinical trial NCT00644800: A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Mania
Delusional Disorder
Acute Exacerbation of Psychosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores
timeFrame: Days 1-3 (end of intramuscular dosing)
Secondary outcomes:
measure: Electrocardiogram at Visits 1 and 5
timeFrame: Visits 1 (Screening) and 5 (Day 7)
measure: Adverse events at Visits 2, 3, 4, and 5
timeFrame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)
measure: Change from baseline in Patient Preference Scale (PPS) scores at Visits 3 and 5
timeFrame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4) and 5 (Day 7)
measure: Laboratory tests at Visits 1 and 5
timeFrame: Visits 1 (Screening) and 5 (Day 7)
measure: Movement disorder rating scale scores (Barnes Akathisia Scale and Extrapyramidal Symptoms Rating Scale) at Visits 2, 3, 4, and 5
timeFrame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)
measure: Change from baseline in PANSS excitation items scores at Visits 3, 4, and 5
timeFrame: Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)
measure: Blood pressure and pulse at Visits 1, 2, and 5
timeFrame: Visits 1 (Screening), 2 (Day 1), and 5 (Day 7)
measure: Change from baseline in Clinical Global Impression-Severity (CGI-S) scores at Visits 3, 4, and 5
timeFrame: Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Pfizer Investigational Site
state: Bahia
city: Fortaleza
country: Brazil
facility: Pfizer Investigational Site
state: Ceara
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Sao Goncalo
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Jardim Santa Monica SN
country: Brazil
facility: Pfizer Investigational Site
state: Salvador - BA
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: