Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00458211
• Other study ID #: BPCIRB 03-02
• Status: Completed
• Phase: Phase 4
• Start date: May 2005
• Est. completion date: April 2008

Study information

• Verified date: April 2020
• Source: Bronx Psychiatric Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
United States	Bronx Psychiatric Center	Bronx	New York
United States	Buffalo Psychiatric Center	Buffalo	New York

Sponsors (4)

Lead Sponsor	Collaborator
Bronx Psychiatric Center	Buffalo Psychiatric Center, Pfizer, Rochester Psychiatric Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia	Minimum score 32 (best) maximum 210 (worst)	Baseline to 8 weeks
Secondary	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
Secondary	Weight		8 weeks
Secondary	Fasting Glucose	Amount of glucose in the blood in mg/dl	8 weeks
Secondary	Cholesterol		8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Barnes Akathisia Scale	Barnes Akathisia Scale measures akathisia: a score of zero is none (good) maximum score is 12	8 weeks
Secondary	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
Secondary	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
Secondary	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