A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis
NCT00644800
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis | |||
Official Title ICMJE | 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 ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | 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 ICMJE | Experimental: Arm A
Intervention: Drug: Ziprasidone | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 89 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Brazil | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00644800 | |||
Other Study ID Numbers ICMJE | A1281074 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |