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Completed

NCT Number: NCT00458211

Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Buffalo Psychiatric Center, Buffalo, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ziprasidone

Drug

Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks

Primary outcomes

  1. Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia

    Time frame: Baseline to 8 weeks

    Minimum score 32 (best) maximum 210 (worst)

Secondary outcomes

  1. Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness.

    Time frame: 8 weeks

    CGI-S scores from 1 = normal to 7 = most extremely ill

  2. Weight

    Time frame: 8 weeks

  3. Fasting Glucose

    Time frame: 8 weeks

    Amount of glucose in the blood in mg/dl

  4. Cholesterol

    Time frame: 8 weeks

  5. Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia

    Time frame: 8 weeks

    Scores 0 (none) to 4 (severe) choreo-athetoid and dystonic movements of seven parts of the body with a maximum score 28

  6. Simpson-Angus Scale Measures Drug Induced Parkinsonism

    Time frame: 8 weeks

    Measures 10 signs, (not all of which are now considered Parkinsonism), minimum score 0 (no Parkinsonism) maximum 40.

  7. Corrected QT Interval (QTc)

    Time frame: 8 weeks

    Time interval between Q and T waves on EKG corrected for pulse rate. Over 500 msec may be dangerous

  8. Brief Assessment of Cognition in Schizophrenia (BACS)

    Time frame: 8 weeks

    Scores on the BACS scale, which measures cognition, were changed to Z-scores based on normal controls from Keefe (2008) A Z-score of zero would indicate cognition the same as the normal controls. Negative scores indicate cognition worse than the normal. Theoretically there are no maximum or minimum scores.

  9. Calgary Depression Scale for Schizophrenia

    Time frame: 8 weeks

    Score on scale, from 0 to 27, above 6 considered indicative of depression, higher scores mean worse outcome,

  10. Personal Evaluation of Transitions in Treatment Scale (PETiTP

    Time frame: 8 weeks

    PETiT is a 30 item self administered scale measuring response to and tolerability and adherence to antipsychotic medication in people with schizophrenia. The range is 30 to 100. Higher scores are better. Although different features are assessed there is a single total score - no subscales.

  11. Medical Outcomes Study Cognitive Functioning Scale (MOS-COG)

    Time frame: 8 weeks

    MOS-COG measures day to day problems in six aspects of cognitive functioning. The scores are converted to 0-100 and so can range from 0 to 100 with 100 being the best. Population means are 70 to 80.

  12. Barnes Akathisia Scale

    Time frame: 8 weeks

    Barnes Akathisia Scale measures akathisia: a score of zero is none (good) maximum score is 12

  13. HbA1c

    Time frame: 8 weeks

    Lab measure of glycated hemoglobin indicative of blood glucose over the last three months. At that time in the US measured as a percentage (of glucose attached to hemoglobin). No maximum or minimum but over 6.5% is generally considered indicative of diabetes.

  14. Insulin Level

    Time frame: 8 weeks

    Measure of the amount of insulin in the blood, in uIU/ml. No minimum or maximum but fasting levels are usually below 25 uIU/ml. After a dose of glucose they may be 30 to 230 uIU/ml.

  15. Antipsychotic Medication Costs

    Time frame: 8 weeks

    No data were collected because it turned out we had no way of measuring the costs.

    No subjects were analysed by costs

Sponsors and collaborators

Lead sponsor

Bronx Psychiatric Center

Other Gov

Collaborators

  • Buffalo Psychiatric Center
  • Pfizer
  • Rochester Psychiatric Center

Registry information

Official study title

Evaluation of Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotic Medications

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Apr 10, 2007
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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