Back to resultsA Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis
Primary Purpose
Schizophrenia, Mania, Delusional Disorder
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Ziprasidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm A
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores
Secondary Outcome Measures
Electrocardiogram at Visits 1 and 5
Adverse events at Visits 2, 3, 4, and 5
Change from baseline in Patient Preference Scale (PPS) scores at Visits 3 and 5
Laboratory tests at Visits 1 and 5
Movement disorder rating scale scores (Barnes Akathisia Scale and Extrapyramidal Symptoms Rating Scale) at Visits 2, 3, 4, and 5
Change from baseline in PANSS excitation items scores at Visits 3, 4, and 5
Blood pressure and pulse at Visits 1, 2, and 5
Change from baseline in Clinical Global Impression-Severity (CGI-S) scores at Visits 3, 4, and 5
Full Information
NCT ID
NCT00644800
First Posted
March 20, 2008
Last Updated
February 18, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00644800
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Mania, Delusional Disorder, Acute Exacerbation of Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Other Intervention Name(s)
Geodon, Zeldox
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores
Time Frame
Days 1-3 (end of intramuscular dosing)
Secondary Outcome Measure Information:
Title
Electrocardiogram at Visits 1 and 5
Time Frame
Visits 1 (Screening) and 5 (Day 7)
Title
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)
Title
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)
Title
Laboratory tests at Visits 1 and 5
Time Frame
Visits 1 (Screening) and 5 (Day 7)
Title
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)
Title
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)
Title
Blood pressure and pulse at Visits 1, 2, and 5
Time Frame
Visits 1 (Screening), 2 (Day 1), and 5 (Day 7)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41180-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60175-270
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-270
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Curitiba
State/Province
PR
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Goncalo
State/Province
RJ
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Jardim Santa Monica SN
State/Province
Salvador - BA
ZIP/Postal Code
40340-720
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281074&StudyName=A%20study%20of%20the%20efficacy%20and%20safety%20of%20intramuscular%20ziprasidone%20followed%20by%20oral%20ziprasidone%20for%20the%20treatment%20of%20psychosis
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis
We'll reach out to this number within 24 hrs