Acute Exacerbation of Psychosis, Delusional Disorder, Mania, Schizophrenia
Conditions
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.
Interventions
DRUGZiprasidone
Intramuscular ziprasidone 10 or 20 mg at the investigator's discretion for 1 to 3 days followed by oral ziprasidone capsules 40 to 80 mg twice daily at the investigator's discretion to complete 7 days of treatment
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores | Days 1-3 (end of intramuscular dosing) |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory tests at Visits 1 and 5 | Visits 1 (Screening) and 5 (Day 7) |
| Electrocardiogram at Visits 1 and 5 | Visits 1 (Screening) 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 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) |
| 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 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) |
| Blood pressure and pulse at Visits 1, 2, and 5 | 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 | Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) |
Countries
Brazil
Outcome results
None listed