Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Buffalo Psychiatric Center | OTHER |
| Rochester Psychiatric Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Open label change to ziprasidone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Weight |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nigel Bark, MD | Bronx Psychiatric Center | Principal Investigator |
| Jeffrey Grace, MD | Buffalo Psychiatric Center | Principal Investigator |
| Steven Schwarzkopf, MD | Rochester Psychiatric Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buffalo Psychiatric Center | Buffalo | New York | 14213 | United States | ||
| Bronx Psychiatric Center |
Not provided
40 subjects from three State Hospitals were recruited and participated between 2005 and 2008: four in-patients from Rochester Psychiatric Center, 17 out-patients from Buffalo Psychiatric Center and 19 in-patients from Bronx Psychiatric Center
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Open label change to ziprasidone up to 120mg twice a day with meals |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The four Rochester subjects were dropped. The 17 Buffalo subjects were all out patients and 20 years older than the 19 Bronx subjects who were all in-patients. Buffalo subjects were 88% white (Bronx 5%), 12% African American (Bronx 39%), 0% Hispanic (Bronx 50%), 24% with Substance abuse (Bronx 68%)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Open label change to ziprasidone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia | Minimum score 32 (best) maximum 210 (worst) | The four Rochester subjects were dropped as Rochester could not continue the study.19 Bronx and 17 Buffalo subjects were analyzed separately because they were so different(see baseline characteristics) | Posted | Mean | Standard Deviation | score on scale | Baseline to 8 weeks |
|
|
Adverse events were collected during the time subjects were in the study - screening till 8 weeks on ziprasidone.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Open label change to ziprasidone |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment | Relapse of out patient required admission |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nigel Bark MD | Bronx Psychiatric Center | 718 862 5429 | Nigel.Bark@omh.ny.gov |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C092292 | ziprasidone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 8 weeks |
| Fasting Glucose | Amount of glucose in the blood in mg/dl | 8 weeks |
| Cholesterol | 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 |
| The Bronx |
| New York |
| 10461 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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 | 17 Buffalo subjects and 19 Bronx subjects | Posted | Mean | Standard Deviation | score on scale | 8 weeks |
|
|
|
| Secondary | Weight | Same as PANNS above | Posted | Mean | Standard Deviation | pounds | 8 weeks |
|
|
|
| Secondary | Fasting Glucose | Amount of glucose in the blood in mg/dl | See PANSS above | Posted | Mean | Standard Deviation | mg/dl | 8 weeks |
|
|
|
| Secondary | Cholesterol | See PANSS above | Posted | Mean | Standard Deviation | mg/dL | 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 | 17 Buffalo subjects and 19 Bronx subjects | Posted | Mean | Standard Deviation | score on scale | 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. | see PANNS above | Posted | Mean | Standard Deviation | score on scale | 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 | Posted | Mean | Standard Deviation | msec | 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. | The overall number of participants is made up of 17 at Buffalo and 19 in the Bronx | Posted | Mean | Standard Deviation | Z-score from score on scale | 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, | 19 at Bronx, 17 at Buffalo | Posted | Mean | Standard Deviation | score on a scale | 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. | 36 subjects entered, 17 at Buffalo and 19 in the Bronx | Posted | Mean | Standard Deviation | score on a scale | 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. | All subjects, 17 at Buffalo, 19 in the Bronx | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Secondary | Barnes Akathisia Scale | Barnes Akathisia Scale measures akathisia: a score of zero is none (good) maximum score is 12 | All subjects entered, 17 at Buffalo, 19 at Bronx | Posted | Mean | Standard Deviation | score on a scale | 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. | All subjects entered, 19 in the Bronx, 17 at Buffalo | Posted | Mean | Standard Deviation | HbA1c | 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. | All subjects entered, 17 at Buffalo, 19 at Bronx | Posted | Mean | Standard Deviation | 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 | We had no measure of costs, no data were collected | Posted | 8 weeks |
|
|
| 1 |
| 40 |
| 0 |
| 40 |
|
Not provided
Not provided
|
| Buffalo end |
|
| Title |
|---|
| Measurements |
|---|
|
| Buffalo end |
|
|
| Buffalo end |
|
|
| Buffalo baseline |
|
|
| Buffalo end |
|
|
| Title | Measurements |
|---|---|
|
| Buffalo baseline |
|
|
| Buffalo end |
|
|
|
| Buffalo baseline |
|
|
| Buffalo end |
|
|
|
| Buffalo baseline |
|
|
| Buffalo end |
|
|
| Title | Measurements |
|---|---|
|
| Buffalo baseline |
|
|
| Buffalo end |
|
|
|
| Buffalo baseline |
|
|
| Buffalo end |
|
|
|
| Buffalo baseline |
|
|
| Buffalo end |
|
|