Trial Outcomes & Findings for Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone (NCT NCT00538642)

Results Overview

Euglycemic clamp method

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Baseline

Results posted on

2012-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	Stay on Current Antipsychotic Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment Subjects switch to ziprasidone from current antipsychotic(s)
Overall Study STARTED	10	14
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stay on Current Antipsychotic n=10 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=14 Participants Subjects switch to ziprasidone from current antipsychotic(s)	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants	14 Participants n=4 Participants	24 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age Continuous	38.6 years STANDARD_DEVIATION 9.05 • n=93 Participants	41.43 years STANDARD_DEVIATION 8.46 • n=4 Participants	40.25 years STANDARD_DEVIATION 8.63 • n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	8 Participants n=4 Participants	14 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	6 Participants n=4 Participants	10 Participants n=27 Participants
Region of Enrollment United States	10 participants n=93 Participants	14 participants n=4 Participants	24 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline

Euglycemic clamp method

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Insulin Sensitivity	5.55 mg glucose/kg.min/μIU insulin Standard Deviation 3.51	1.88 mg glucose/kg.min/μIU insulin Standard Deviation 1.08

PRIMARY outcome

Timeframe: 4-5 months

Euglycemic clamp method

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Insulin Sensitivity	6.01 mg glucose/kg.min/μIU insulin Standard Deviation 3.93	2.07 mg glucose/kg.min/μIU insulin Standard Deviation 1.15

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Body Mass Index	38.4 Kg/m2 Standard Deviation 10.5	39.0 Kg/m2 Standard Deviation 4.1

SECONDARY outcome

Timeframe: 4-5 months

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Body Mass Index	36.0 Kg/m2 Standard Deviation 6.4	38.8 Kg/m2 Standard Deviation 4.2

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Abdominal Circumference	115 cm Standard Deviation 20	126 cm Standard Deviation 17

SECONDARY outcome

Timeframe: 4-5 months

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Abdominal Circumference	115 cm Standard Deviation 19	122 cm Standard Deviation 8

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Systolic Blood Pressure	118 mm Hg Standard Deviation 15	121 mm Hg Standard Deviation 13

SECONDARY outcome

Timeframe: 4-5 months

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Systolic Blood Pressure	123 mm Hg Standard Deviation 15	128 mm Hg Standard Deviation 15

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Diastolic Blood Pressure	81 mm Hg Standard Deviation 10	80 mm Hg Standard Deviation 9

SECONDARY outcome

Timeframe: 4-5 months

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Diastolic Blood Pressure	82 mm Hg Standard Deviation 9	81 mm Hg Standard Deviation 13

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Triglycerides	183 mg/dL Standard Deviation 166	227 mg/dL Standard Deviation 154

SECONDARY outcome

Timeframe: 4-5 months

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Triglycerides	154 mg/dL Standard Deviation 87	252 mg/dL Standard Deviation 179

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Cholesterol	176 mg/dL Standard Deviation 53	176 mg/dL Standard Deviation 36

SECONDARY outcome

Timeframe: 4-5 months

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
Cholesterol	177 mg/dL Standard Deviation 34	186 mg/dL Standard Deviation 44

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
HDL Cholesterol	34 mg/dL Standard Deviation 8	35 mg/dL Standard Deviation 5

SECONDARY outcome

Timeframe: 4-5 months

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
HDL Cholesterol	40 mg/dL Standard Deviation 9	38 mg/dL Standard Deviation 9

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
LDL Cholesterol	108 mg/dL Standard Deviation 43	106 mg/dL Standard Deviation 35

SECONDARY outcome

Timeframe: 4-5 months

Outcome measures

Outcome measures
Measure	Stay on Current Antipsychotic n=9 Participants Subjects stay on same antipsychotic treatment as at baseline.	Ziprasidone Treatment n=9 Participants Subjects switch to ziprasidone from current antipsychotic(s)
LDL Cholesterol	106 mg/dL Standard Deviation 29	109 mg/dL Standard Deviation 35

Adverse Events

Stay on Current Antipsychotic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ziprasidone Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alexander Miller

University of Texas Health Science Center at San Antonio

Phone: 210-567-5508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60