NCT00644800CompletedPhase 4
An Open, Multicenter, Non-Comparative Study To Assess The Efficacy And Tolerability Of Intramuscular Ziprasidone Followed By Oral Ziprasidone In Patients With Acute Psychosis
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country89 target enrollmentStarted: July 2003Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Arm A
Experimental
Intervention: Ziprasidone (Drug)
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
- 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))
- 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))
- 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))
Investigators
Study Sites (1)
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