Trial Outcomes & Findings for Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes (NCT NCT00338949)
NCT ID: NCT00338949
Last Updated: 2020-10-30
Results Overview
As measured by frequently sampled intravenous glucose tolerance testing (units: 1/mU/L) x 1/Min)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
77 participants
Primary outcome timeframe
Measured at Baseline and Week 26
Results posted on
2020-10-30
Participant Flow
Recruitment started 06/01/2006. Eligibility: nondiabetic, overweight/obese psychiatrically stable adult outpatients in San Diego with schizophrenia/schizoaffective disorder, on risperidone or olanzapine. Recruitment ended: 12/31/2009
Exclusions: unstable housing, psychiatric hospitalization in the past 90 days, ongoing substance abuse (except nicotine), history of diabetes mellitus, pregnancy, refractory schizophrenia, prior failure of or intolerance to ziprasidone, oral glucose tolerance test indicative of diabetes mellitus, or corrected QT interval ≥ 500 msec on EKG.
Participant milestones
| Measure |
Switch
Switch from risperidone or olanzapine to ziprasidone. Ziprasidone will be flexibly dosed based on tolerability and psychiatric response (max dose 200 PO mg/d with food).
|
Control
Remain on risperidone or olanzapine.
|
|---|---|---|
|
Subject Screening
STARTED
|
41
|
36
|
|
Subject Screening
COMPLETED
|
30
|
25
|
|
Subject Screening
NOT COMPLETED
|
11
|
11
|
|
Randomization
STARTED
|
30
|
25
|
|
Randomization
COMPLETED
|
25
|
24
|
|
Randomization
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Switch
Switch from risperidone or olanzapine to ziprasidone. Ziprasidone will be flexibly dosed based on tolerability and psychiatric response (max dose 200 PO mg/d with food).
|
Control
Remain on risperidone or olanzapine.
|
|---|---|---|
|
Subject Screening
Screen failures
|
11
|
11
|
|
Randomization
Withdrawal by Subject
|
0
|
1
|
|
Randomization
Adverse Event
|
5
|
0
|
Baseline Characteristics
Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes
Baseline characteristics by cohort
| Measure |
Control
n=25 Participants
Remain on risperidone or olanzapine.
|
Switch
n=30 Participants
Switch from risperidone or olanzapine to ziprasidone. Ziprasidone will be flexibly dosed based on tolerability and psychiatric response (max dose 200 PO mg/d with food).
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.15 Years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
48.73 Years
STANDARD_DEVIATION 8.42 • n=7 Participants
|
48.00 Years
STANDARD_DEVIATION 8.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
30 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Family Diabetes Mellitus History
Family Hx
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Family Diabetes Mellitus History
No Family Hx
|
21 participants
n=5 Participants
|
25 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Smoking Status
Smoker
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Smoking Status
Nonsmoker
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
BMI
|
32.52 kg/m^2
STANDARD_DEVIATION 4.49 • n=5 Participants
|
34.64 kg/m^2
STANDARD_DEVIATION 7.60 • n=7 Participants
|
33.68 kg/m^2
STANDARD_DEVIATION 6.19 • n=5 Participants
|
|
Baseline Antipsychotic
Risperidone
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Baseline Antipsychotic
Olanzapine
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
PANSS Total Score
|
62.72 units on a scale
STANDARD_DEVIATION 11.70 • n=5 Participants
|
65.20 units on a scale
STANDARD_DEVIATION 10.66 • n=7 Participants
|
64.07 units on a scale
STANDARD_DEVIATION 11.13 • n=5 Participants
|
|
Central visceral fat volume by CT
|
28442 mm^3
STANDARD_DEVIATION 10634 • n=5 Participants
|
26939 mm^3
STANDARD_DEVIATION 12060 • n=7 Participants
|
27622 mm^3
STANDARD_DEVIATION 11412 • n=5 Participants
|
|
Insulin sensitivity index
|
1.596 (1/mU/L) x 1/Min
STANDARD_DEVIATION 1.00 • n=5 Participants
|
1.504 (1/mU/L) x 1/Min
STANDARD_DEVIATION 0.902 • n=7 Participants
|
1.55 (1/mU/L) x 1/Min
STANDARD_DEVIATION 0.95 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Baseline and Week 26Population: Completers
As measured by frequently sampled intravenous glucose tolerance testing (units: 1/mU/L) x 1/Min)
Outcome measures
| Measure |
Control
n=24 Participants
Remain on risperidone or olanzapine.
|
Switch
n=25 Participants
Switch from risperidone or olanzapine to ziprasidone. Ziprasidone will be flexibly dosed based on tolerability and psychiatric response (max dose 200 PO mg/d with food).
|
|---|---|---|
|
Change in Insulin Sensitivity Index From Baseline to Week 26 ((1/mU/L) x 1/Min)
|
0.072 (1/mU/L) x 1/Min
Standard Deviation 0.955
|
0.407 (1/mU/L) x 1/Min
Standard Deviation 0.822
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: Completers
CT measured change in visceral fat mass from baseline to week 26 (mm\^3)
Outcome measures
| Measure |
Control
n=24 Participants
Remain on risperidone or olanzapine.
|
Switch
n=25 Participants
Switch from risperidone or olanzapine to ziprasidone. Ziprasidone will be flexibly dosed based on tolerability and psychiatric response (max dose 200 PO mg/d with food).
|
|---|---|---|
|
Change in Visceral Fat Mass From Baseline to Week 26
|
315 mm^3
Standard Deviation 5693
|
392 mm^3
Standard Deviation 4340
|
Adverse Events
Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Switch
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=25 participants at risk
Remain on risperidone or olanzapine.
|
Switch
n=30 participants at risk
Switch from risperidone or olanzapine to ziprasidone. Ziprasidone will be flexibly dosed based on tolerability and psychiatric response (max dose 200 PO mg/d with food).
|
|---|---|---|
|
Psychiatric disorders
Psychiatric exacerbation
|
4.0%
1/25 • Number of events 1 • 6 months
|
6.7%
2/30 • Number of events 2 • 6 months
|
Other adverse events
| Measure |
Control
n=25 participants at risk
Remain on risperidone or olanzapine.
|
Switch
n=30 participants at risk
Switch from risperidone or olanzapine to ziprasidone. Ziprasidone will be flexibly dosed based on tolerability and psychiatric response (max dose 200 PO mg/d with food).
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/25 • 6 months
|
6.7%
2/30 • Number of events 2 • 6 months
|
|
Psychiatric disorders
Akathisia
|
0.00%
0/25 • 6 months
|
3.3%
1/30 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place