Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Drug: 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 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: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Bronx Psychiatric Center
    • Buffalo, New York, United States, 14213
      • Buffalo Psychiatric Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; Open label change to ziprasidone	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia	Minimum score 32 (best) maximum 210 (worst)	Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight		8 weeks
Cholesterol		8 weeks
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	8 weeks
Fasting Glucose	Amount of glucose in the blood in mg/dl	8 weeks
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	8 weeks
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.	8 weeks
Corrected QT Interval (QTc)	Time interval between Q and T waves on EKG corrected for pulse rate. Over 500 msec may be dangerous	8 weeks
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.	8 weeks
Calgary Depression Scale for Schizophrenia	Score on scale, from 0 to 27, above 6 considered indicative of depression, higher scores mean worse outcome,	8 weeks
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.	8 weeks
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.	8 weeks
Barnes Akathisia Scale	Barnes Akathisia Scale measures akathisia: a score of zero is none (good) maximum score is 12	8 weeks
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.	8 weeks
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.	8 weeks
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	8 weeks

Collaborators and Investigators

• Sponsor: Bronx Psychiatric Center
• Collaborators: Pfizer; Buffalo Psychiatric Center; Rochester Psychiatric Center
• Investigators: Principal Investigator: Jeffrey Grace, MD, Buffalo Psychiatric Center; Principal Investigator: Steven Schwarzkopf, MD, Rochester Psychiatric Center

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (ACTUAL): April 1, 2008
• Study Completion (ACTUAL): April 1, 2008

Study Registration Dates

• First Submitted: April 6, 2007
• First Submitted That Met QC Criteria: April 9, 2007
• First Posted (ESTIMATE): April 10, 2007

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Schizophrenia; Ziprasidone
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Ziprasidone
• Other Study ID Numbers: BPCIRB 03-02