Trial Outcomes & Findings for Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics (NCT NCT00458211)

NCT ID: NCT00458211

Last Updated: 2020-05-01

Results Overview

Minimum score 32 (best) maximum 210 (worst)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: Baseline to 8 weeks
• Results posted on: 2020-05-01

Participant Flow

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

Participant milestones

Measure	Experimental Open label change to ziprasidone up to 120mg twice a day with meals
Overall Study STARTED	40
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	Experimental Open label change to ziprasidone up to 120mg twice a day with meals
Overall Study Lack of Efficacy	12
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	2

Baseline Characteristics

Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics

Baseline characteristics by cohort

Measure	Experimental n=40 Participants Open label change to ziprasidone
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	42 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Population: 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)

Minimum score 32 (best) maximum 210 (worst)

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia Bronx baseline	95 score on scale Standard Deviation 16
Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia Bronx end	99 score on scale Standard Deviation 25
Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia Buffalo baseline	72 score on scale Standard Deviation 22
Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia Buffalo end	62 score on scale Standard Deviation 19

SECONDARY outcome

Timeframe: 8 weeks

Population: 17 Buffalo subjects and 19 Bronx subjects

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

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness. Bronx baseline	4.6 score on scale Standard Deviation 0.6
Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness. Bronx end	4.9 score on scale Standard Deviation 0.8
Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness. Buffalo baseline	3.5 score on scale Standard Deviation 0.9
Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness. Buffalo end	2.8 score on scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 8 weeks

Population: Same as PANNS above

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Weight Bronx baseline	195 pounds Standard Deviation 43
Weight Bronx end	193 pounds Standard Deviation 41
Weight Buffalo baseline	213 pounds Standard Deviation 57
Weight Buffalo end	204 pounds Standard Deviation 52

SECONDARY outcome

Timeframe: 8 weeks

Population: See PANSS above

Amount of glucose in the blood in mg/dl

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Fasting Glucose Bronx end	82 mg/dl Standard Deviation 24
Fasting Glucose Buffalo baseline	94 mg/dl Standard Deviation 18
Fasting Glucose Buffalo end	93 mg/dl Standard Deviation 19
Fasting Glucose Bronx baseline	91 mg/dl Standard Deviation 28

SECONDARY outcome

Timeframe: 8 weeks

Population: See PANSS above

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Cholesterol Bronx baseline	185 mg/dL Standard Deviation 44
Cholesterol Bronx end	160 mg/dL Standard Deviation 28
Cholesterol Buffalo baseline	186 mg/dL Standard Deviation 42
Cholesterol Buffalo end	179 mg/dL Standard Deviation 36

SECONDARY outcome

Timeframe: 8 weeks

Population: 17 Buffalo subjects and 19 Bronx subjects

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

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia Bronx end	0.3 score on scale Standard Deviation 0.7
Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia Buffalo baseline	2.9 score on scale Standard Deviation 3.1
Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia Bronx baseline	0.3 score on scale Standard Deviation 0.8
Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia Buffalo end	1.6 score on scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 8 weeks

Population: see PANNS above

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

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Simpson-Angus Scale Measures Drug Induced Parkinsonism Bronx baseline	0.2 score on scale Standard Deviation 0.5
Simpson-Angus Scale Measures Drug Induced Parkinsonism Bronx end	0.1 score on scale Standard Deviation 0.2
Simpson-Angus Scale Measures Drug Induced Parkinsonism Buffalo baseline	3.6 score on scale Standard Deviation 3.6
Simpson-Angus Scale Measures Drug Induced Parkinsonism Buffalo end	2.5 score on scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Corrected QT Interval (QTc) Bronx baseline	396 msec Standard Deviation 18
Corrected QT Interval (QTc) Bronx end	411 msec Standard Deviation 15
Corrected QT Interval (QTc) Buffalo baeline	412 msec Standard Deviation 21
Corrected QT Interval (QTc) Buffalo end	427 msec Standard Deviation 17

SECONDARY outcome

Timeframe: 8 weeks

Population: The overall number of participants is made up of 17 at Buffalo and 19 in the Bronx

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.

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Brief Assessment of Cognition in Schizophrenia (BACS) Bronx baseline	-14 Z-score from score on scale Standard Deviation 6.0
Brief Assessment of Cognition in Schizophrenia (BACS) Bronx end	-13 Z-score from score on scale Standard Deviation 5.3
Brief Assessment of Cognition in Schizophrenia (BACS) Buffalo baseline	-12 Z-score from score on scale Standard Deviation 5.9
Brief Assessment of Cognition in Schizophrenia (BACS) Buffalo end	-11 Z-score from score on scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: 8 weeks

Population: 19 at Bronx, 17 at Buffalo

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

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Calgary Depression Scale for Schizophrenia Bronx baseline	5.4 score on a scale Standard Deviation 4.4
Calgary Depression Scale for Schizophrenia Bronx end	5.3 score on a scale Standard Deviation 3.8
Calgary Depression Scale for Schizophrenia Buffalo baseline	3.4 score on a scale Standard Deviation 3.7
Calgary Depression Scale for Schizophrenia Buffalo end	1.3 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 8 weeks

Population: 36 subjects entered, 17 at Buffalo and 19 in the Bronx

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.

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Personal Evaluation of Transitions in Treatment Scale (PETiTP Bronx baseline	43 score on a scale Standard Deviation 9.7
Personal Evaluation of Transitions in Treatment Scale (PETiTP Bronx end	45 score on a scale Standard Deviation 11
Personal Evaluation of Transitions in Treatment Scale (PETiTP Buffalo baseline	46 score on a scale Standard Deviation 11
Personal Evaluation of Transitions in Treatment Scale (PETiTP Buffalo end	48 score on a scale Standard Deviation 13

SECONDARY outcome

Timeframe: 8 weeks

Population: All subjects, 17 at Buffalo, 19 in the Bronx

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.

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Medical Outcomes Study Cognitive Functioning Scale (MOS-COG) Bronx baseline	17 score on a scale Standard Deviation 5.8
Medical Outcomes Study Cognitive Functioning Scale (MOS-COG) Bronx end	16 score on a scale Standard Deviation 6.3
Medical Outcomes Study Cognitive Functioning Scale (MOS-COG) Buffalo baseline	18 score on a scale Standard Deviation 5.4
Medical Outcomes Study Cognitive Functioning Scale (MOS-COG) Buffalo end	19 score on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: 8 weeks

Population: All subjects entered, 17 at Buffalo, 19 at Bronx

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

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Barnes Akathisia Scale Bronx baseline	0.6 score on a scale Standard Deviation 1.7
Barnes Akathisia Scale Bronx end	0.8 score on a scale Standard Deviation 1.7
Barnes Akathisia Scale Buffalo baseline	1.4 score on a scale Standard Deviation 1.5
Barnes Akathisia Scale Buffalo end	1.1 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 8 weeks

Population: All subjects entered, 19 in the Bronx, 17 at Buffalo

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.

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
HbA1c Bronx baseline	5.3 HbA1c Standard Deviation 0.6
HbA1c Bronx end	5.4 HbA1c Standard Deviation 0.7
HbA1c Buffalo baseline	6.0 HbA1c Standard Deviation 0.9
HbA1c Buffalo end	5.7 HbA1c Standard Deviation 0.8

SECONDARY outcome

Timeframe: 8 weeks

Population: All subjects entered, 17 at Buffalo, 19 at Bronx

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.

Outcome measures

Measure	Experimental n=36 Participants Open label change to ziprasidone
Insulin Level Bronx baseline	10 uIU/ml Standard Deviation 7.2
Insulin Level Bronx end	13 uIU/ml Standard Deviation 14
Insulin Level Buffalo baseline	12 uIU/ml Standard Deviation 9.2
Insulin Level Buffalo end	17 uIU/ml Standard Deviation 14

SECONDARY outcome

Timeframe: 8 weeks

Population: We had no measure of costs, no data were collected

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

No subjects were analysed by costs

Outcome measures

Outcome data not reported

Adverse Events

Experimental

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Experimental n=40 participants at risk Open label change to ziprasidone
Psychiatric disorders Hospitalization	2.5% 1/40 • Number of events 1 • Adverse events were collected during the time subjects were in the study - screening till 8 weeks on ziprasidone.

Other adverse events

Adverse event data not reported

Additional Information

Nigel Bark MD

Bronx Psychiatric Center

Phone: 718 862 5429

Email: Nigel.Bark@omh.ny.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place