Clinical Trial: A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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.
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome: Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores [ Time Frame: Days 1-3 (end of intramuscular dosing) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Electrocardiogram at Visits 1 and 5 [ Time Frame: Visits 1 (Screening) and 5 (Day 7) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
Original Secondary Outcome: Same as current
Information By: Pfizer
Dates:
Date Received: March 20, 2008
Date Started: July 2003
Date Completion:
Last Updated: April 7, 2008
Last Verified: April 2008