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

• ClinicalTrials.gov Identifier: NCT00644800
• Recruitment Status: Completed
• First Posted: March 27, 2008
• Last Update Posted: February 21, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information

• First Submitted Date: March 20, 2008
• First Posted Date: March 27, 2008
• Last Update Posted Date: February 21, 2021
• Study Start Date: July 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: March 20, 2008): 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 Measures: Same as current

Current Secondary Outcome Measures (submitted: March 20, 2008)

• 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 Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis
• 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 Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Schizophrenia
• Mania
• Delusional Disorder
• Acute Exacerbation of Psychosis

Intervention

Drug: Ziprasidone

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

Other Name: Geodon, Zeldox

Study Arms

Experimental: Arm A

Intervention: Drug: Ziprasidone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 20, 2008): 89
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2004
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT00644800
• Other Study ID Numbers: A1281074
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: February 2021