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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00644800
• Date of registration: 20/03/2008
• Primary sponsor: Pfizer
• Public title: A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis
• Scientific 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
• Date of first enrolment: July 2003
• Target sample size: 89
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00644800
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Brazil

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Exacerbation of Psychosis

Delusional Disorder

Mania

Schizophrenia

Intervention(s)

Drug: Ziprasidone

Primary Outcome(s)

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

Secondary Outcome(s)

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)]

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)]

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)]

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)]

Electrocardiogram at Visits 1 and 5 [Time Frame: Visits 1 (Screening) 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)]

Secondary ID(s)

A1281074

Source(s) of Monetary Support

Please refer to primary and secondary sponsors