CompletedPhase 4

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

Brazil89 participantsStarted 2003-07

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Days 1-3 (end of intramuscular dosing)

Trial details

NCT IDNCT00644800

SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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