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Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Buffalo Psychiatric Center
Rochester Psychiatric Center
Information provided by (Responsible Party):
Nigel Bark MD, Bronx Psychiatric Center
ClinicalTrials.gov Identifier:
NCT00458211
First received: April 6, 2007
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
 Drug: ziprasidone
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotic Medications

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bronx Psychiatric Center:

Primary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    Minimum score 32 (best) maximum 210 (worst)


Secondary Outcome Measures:
  • Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    CGI-S scores from 1 = normal to 7 = most extremely ill

  • Weight [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Fasting Glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Scores 0 (none) to 4 (severe) chore-athetoid and dystonic movements of seven parts of the body with a maximum score 28

  • Simpson-Angus Scale Measures Drug Induced Parkinsonism [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Measures 10 signs, (not all of which are now considered Parkinsonism), minimum score 0 (no Parkinsonism) maximum 40.

  • QTc [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Time interval between Q and T waves on EKG corrected for pulse rate. Over 500 msec may be dangerous

  • BACS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CDSS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • PETiT [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • MOS-COG [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Barnes Akathisia Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • HgbA1c [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Insulin Level [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Antipsychotic Medication Costs [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Open label change to ziprasidone
 Drug: ziprasidone
Ziprasidone by mouth 40mg bid for one day, then 80mg bid; may be increased to 120mg bid after three weeks
Other Name: Ziprasidone

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 CGI, 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, AIMS and Barnes), 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458211

Locations
United States, New York
Bronx Psychiatric Center
Bronx, New York, United States, 10461
Buffalo Psychiatric Center
Buffalo, New York, United States, 14213
Sponsors and Collaborators
Bronx Psychiatric Center
Pfizer
Buffalo Psychiatric Center
Rochester Psychiatric Center
Investigators
Principal Investigator: Nigel Bark, MD Bronx Psychiatric Center
Principal Investigator: Jeffrey Grace, MD Buffalo Psychiatric Center
Principal Investigator: Steven Schwarzkopf, MD Rochester Psychiatric Center
  More Information

No publications provided

Responsible Party: Nigel Bark MD, Director of Scizophrenia Research, Bronx Psychiatric Center
ClinicalTrials.gov Identifier: NCT00458211     History of Changes
Other Study ID Numbers: BPCIRB 03-02
Study First Received: April 6, 2007
Results First Received: April 25, 2012
Last Updated: March 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Bronx Psychiatric Center:
Schizophrenia
Ziprasidone

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Ziprasidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 16, 2013