Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics

NCT00458211

Last updated date
Study Location
Bronx Psychiatric Center
Bronx, New York, 10461, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia, Schizoaffective Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Schizophrenia or schizoaffective

- Capacity to give consent

- Stable, on the same medication for a month but only partial response or with unacceptable side effects 18-65 years of age

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Repeated non-compliance


- Current depot medication


- Active medical conditions


- QTc >500msec


- Previous non-response


- Previous treatment with ziprasidone

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics
Official Title  ICMJE Evaluation of Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotic Medications
Brief Summary

Because ziprasidone has not been extensively studied and is not widely accepted in the severely mentally ill in State hospitals this study aims to demonstrate its effectiveness and relative lack of side effects. 75 patients with schizophrenia or schizoaffective disorder who need a change of medication because of ineffectiveness or side effects will be changed to ziprasidone and followed with detailed assessments for eight weeks.

The hypothesis is that they will improve and have fewer side effects.

Detailed Description

Ziprasidone has been found in studies and practice to be efficacious and tolerated well but has not been well studied or well accepted in the very severely ill in State Hospitals. This study aims to fill that gap by examining 75 patients with schizophrenia or schizoaffective disorder who require a change of medication because of poor response or unacceptable side effects.

After signing consent and having a baseline assessment they will, if necessary, be reduced to one antipsychotic then started on ziprasidone, increasing to 160mg the second day. The one antipsychotic they had been on will be reduced over a week and stopped. The ziprasidone can be increased to 240mg after three weeks if necessary.

The study will last eight weeks with efficacy assessed by Clinical Global Impressions (CGI), Positive and Negative Syndrome Scale (PANSS) every two weeks and Brief Assessment of Cognition, Calgary Depression Scale for Schizophrenia, Personal Evaluation of Transitions in Treatment and Medical Outcomes Study Cognitive Questions at the beginning and end. Side effects will be measured by movement disorder scales (Simpson-Angus scale for Parkinsonism (SANRS), Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Scale (BAS)), ECG and weight and blood metabolic measures.

The hypothesis is that ziprasidone will be generally effective and that side effects especially metabolic indices will be reduced.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
Intervention  ICMJE Drug: ziprasidone
Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks
Study Arms  ICMJE Experimental: Experimental
Open label change to ziprasidone
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
 (submitted: May 1, 2008)
40
Original Enrollment  ICMJE
 (submitted: April 9, 2007)
75
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Schizophrenia or schizoaffective
  • Capacity to give consent
  • Stable, on the same medication for a month but only partial response or with unacceptable side effects 18-65 years of age

Exclusion Criteria:

  • Repeated non-compliance
  • Current depot medication
  • Active medical conditions
  • QTc >500msec
  • Previous non-response
  • Previous treatment with ziprasidone
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00458211
Other Study ID Numbers  ICMJE BPCIRB 03-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nigel Bark MD, Bronx Psychiatric Center
Study Sponsor  ICMJE Bronx Psychiatric Center
Collaborators  ICMJE
  • Pfizer
  • Buffalo Psychiatric Center
  • Rochester Psychiatric Center
Investigators  ICMJE
Principal Investigator:Nigel Bark, MDBronx Psychiatric Center
Principal Investigator:Jeffrey Grace, MDBuffalo Psychiatric Center
Principal Investigator:Steven Schwarzkopf, MDRochester Psychiatric Center
PRS Account Bronx Psychiatric Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP