Clinical trial NCT00458211: Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics
Official title: Evaluation of Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotic Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Ziprasidone
Lead sponsor: Bronx Psychiatric Center
Sponsor class: OTHER_GOV
Collaborators: name: Pfizer
name: Buffalo Psychiatric Center
name: Rochester Psychiatric Center
First posted: 2007-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness.
timeFrame: 8 weeks
measure: Weight
timeFrame: 8 weeks
measure: Fasting Glucose
timeFrame: 8 weeks
measure: Cholesterol
timeFrame: 8 weeks
measure: Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia
timeFrame: 8 weeks
measure: Simpson-Angus Scale Measures Drug Induced Parkinsonism
timeFrame: 8 weeks
measure: Corrected QT Interval (QTc)
timeFrame: 8 weeks
measure: Brief Assessment of Cognition in Schizophrenia (BACS)
timeFrame: 8 weeks
measure: Calgary Depression Scale for Schizophrenia
timeFrame: 8 weeks
measure: Personal Evaluation of Transitions in Treatment Scale (PETiTP
timeFrame: 8 weeks
measure: Medical Outcomes Study Cognitive Functioning Scale (MOS-COG)
timeFrame: 8 weeks
measure: Barnes Akathisia Scale
timeFrame: 8 weeks
measure: HbA1c
timeFrame: 8 weeks
measure: Insulin Level
timeFrame: 8 weeks
measure: Antipsychotic Medication Costs
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx Psychiatric Center
state: New York
city: Buffalo
country: United States
facility: Buffalo Psychiatric Center
state: New York
Study officials:
affiliation: Bronx Psychiatric Center
name: Nigel Bark, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Buffalo Psychiatric Center
name: Jeffrey Grace, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rochester Psychiatric Center
name: Steven Schwarzkopf, MD
role: PRINCIPAL_INVESTIGATOR
References: