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SchizophreniaPhase 4NCT00458211

Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics

A Phase 4 study testing ziprasidone in people with Schizophrenia and Schizoaffective Disorder, run by Bronx Psychiatric Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia, Schizoaffective Disorder
What is being tested?
ziprasidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
May 2005to Apr 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Repeated non-compliance
  • Current depot medication
  • Active medical conditions
  • QTc >500msec
  • Previous non-response
  • Previous treatment with ziprasidone

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Buffalo Psychiatric Center

    Buffalo, New York, 14213

  • Bronx Psychiatric Center

    The Bronx, New York, 10461

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
ziprasidone
Keywords
Schizophrenia, Ziprasidone
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ziprasidoneDrug

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

Study groups in NCT00458211
Study groupRoleWhat they receive
ExperimentalExperimentalOpen label change to ziprasidone
Receives: Drug: ziprasidone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Minimum score 32 (best) maximum 210 (worst)

    Measured: Baseline to 8 weeks

Secondary outcomes (15)

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

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

    Measured: 8 weeks

  2. Weight

    Measured: 8 weeks

  3. Fasting Glucose

    Amount of glucose in the blood in mg/dl

    Measured: 8 weeks

  4. Cholesterol

    Measured: 8 weeks

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

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

    Measured: 8 weeks

  6. Simpson-Angus Scale Measures Drug Induced Parkinsonism

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

    Measured: 8 weeks

  7. Corrected QT Interval (QTc)

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

    Measured: 8 weeks

  8. Brief Assessment of Cognition in Schizophrenia (BACS)

    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.

    Measured: 8 weeks

  9. Calgary Depression Scale for Schizophrenia

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

    Measured: 8 weeks

  10. Personal Evaluation of Transitions in Treatment Scale (PETiTP

    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.

    Measured: 8 weeks

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

    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.

    Measured: 8 weeks

  12. Barnes Akathisia Scale

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

    Measured: 8 weeks

  13. HbA1c

    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.

    Measured: 8 weeks

  14. Insulin Level

    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.

    Measured: 8 weeks

  15. Antipsychotic Medication Costs

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

    No subjects were analysed by costs

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2007 (estimated)
  2. Study startMay 2005
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00458211
Sponsor's protocol ID
BPCIRB 03-02
Status last verified
Apr 2020
First submitted
6 Apr 2007
Last updated
1 May 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ziprasidone in people with Schizophrenia and Schizoaffective Disorder, run by Bronx Psychiatric Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00458211.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.

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