Bipolar Disorder, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
schizophrenia, antipsychotics, diabetes, bipolar disorder
Brief summary
Having a diagnosis of schizophrenia or bipolar disorder and being treated with certain of the newer antipsychotics are risk factors for development of diabetes. Subjects with these risk factors plus obesity and/or family history of diabetes who agree to study participation will undergo an oral glucose tolerance test. If the oral glucose tolerance test demonstrates that the subject is pre-diabetic (elevated glucose levels, but below the diabetic range), he/she will have his/her insulin resistance level measured, prior to random assignment to either stay on current antipsychotic medication or switch to ziprasidone. Insulin resistance will be measured again after four months. The primary hypothesis is that insulin resistance will decrease in those switched to ziprasidone relative to those continuing on their same antipsychotic medication.
Interventions
DRUGziprasidone
Patients assigned to ziprasidone arm are cross-titrated from current antipsychotic
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder * BMI\>29.9 or family history of diabetes and/or abdominal circumference greater than 88 cm in women or 102 cm in men * Pre-diabetic oral glucose tolerance test * Current treatment with olanzapine, risperidone, paliperidone, or quetiapine, or combination of these * Willing to switch to ziprasidone * No psychiatric hospitalizations in past three months and judged by treating clinician to be suitable for antipsychotic medication switch * Able to give informed consent to study
Exclusion criteria
* Judged to be currently suicidal, homicidal, or unable to cooperate with treatment * Unstable serious medical illness * Current use of drugs that interfere with glucose and fat metabolism (sulfonylureas, metformin, thiazolidinediones). The use of statins and fibrates will be allowed ONLY if stable dose for past 3 months. * Current diagnosis of diabetes * Fasting blood glucose \>125 mg/dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Sensitivity | Baseline | Euglycemic clamp method |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal Circumference | Baseline |
| Systolic Blood Pressure | Baseline |
| Diastolic Blood Pressure | Baseline |
| Body Mass Index | Baseline |
| Cholesterol | Baseline |
| HDL Cholesterol | Baseline |
| LDL Cholesterol | Baseline |
| Triglycerides | Baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stay on Current Antipsychotic Subjects stay on same antipsychotic treatment as at baseline. | 10 |
| Ziprasidone Treatment Subjects switch to ziprasidone from current antipsychotic(s) | 14 |
| Total | 24 |
Baseline characteristics
| Characteristic | Ziprasidone Treatment | Stay on Current Antipsychotic | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 10 Participants | 24 Participants |
| Age Continuous | 41.43 years STANDARD_DEVIATION 8.46 | 38.6 years STANDARD_DEVIATION 9.05 | 40.25 years STANDARD_DEVIATION 8.63 |
| Region of Enrollment United States | 14 participants | 10 participants | 24 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 14 |
| serious Total, serious adverse events | 0 / 10 | 0 / 14 |
Outcome results
Primary
Insulin Sensitivity
Euglycemic clamp method
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Insulin Sensitivity | 5.55 mg glucose/kg.min/μIU insulin | Standard Deviation 3.51 |
| Ziprasidone Treatment | Insulin Sensitivity | 1.88 mg glucose/kg.min/μIU insulin | Standard Deviation 1.08 |
p-value: <0.05ANOVA
Primary
Insulin Sensitivity
Euglycemic clamp method
Time frame: 4-5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Insulin Sensitivity | 6.01 mg glucose/kg.min/μIU insulin | Standard Deviation 3.93 |
| Ziprasidone Treatment | Insulin Sensitivity | 2.07 mg glucose/kg.min/μIU insulin | Standard Deviation 1.15 |
Secondary
Abdominal Circumference
Time frame: 4-5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Abdominal Circumference | 115 cm | Standard Deviation 19 |
| Ziprasidone Treatment | Abdominal Circumference | 122 cm | Standard Deviation 8 |
Secondary
Abdominal Circumference
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Abdominal Circumference | 115 cm | Standard Deviation 20 |
| Ziprasidone Treatment | Abdominal Circumference | 126 cm | Standard Deviation 17 |
Secondary
Body Mass Index
Time frame: 4-5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Body Mass Index | 36.0 Kg/m2 | Standard Deviation 6.4 |
| Ziprasidone Treatment | Body Mass Index | 38.8 Kg/m2 | Standard Deviation 4.2 |
Secondary
Body Mass Index
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Body Mass Index | 38.4 Kg/m2 | Standard Deviation 10.5 |
| Ziprasidone Treatment | Body Mass Index | 39.0 Kg/m2 | Standard Deviation 4.1 |
Secondary
Cholesterol
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Cholesterol | 176 mg/dL | Standard Deviation 53 |
| Ziprasidone Treatment | Cholesterol | 176 mg/dL | Standard Deviation 36 |
Secondary
Cholesterol
Time frame: 4-5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Cholesterol | 177 mg/dL | Standard Deviation 34 |
| Ziprasidone Treatment | Cholesterol | 186 mg/dL | Standard Deviation 44 |
Secondary
Diastolic Blood Pressure
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Diastolic Blood Pressure | 81 mm Hg | Standard Deviation 10 |
| Ziprasidone Treatment | Diastolic Blood Pressure | 80 mm Hg | Standard Deviation 9 |
Secondary
Diastolic Blood Pressure
Time frame: 4-5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Diastolic Blood Pressure | 82 mm Hg | Standard Deviation 9 |
| Ziprasidone Treatment | Diastolic Blood Pressure | 81 mm Hg | Standard Deviation 13 |
Secondary
HDL Cholesterol
Time frame: 4-5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | HDL Cholesterol | 40 mg/dL | Standard Deviation 9 |
| Ziprasidone Treatment | HDL Cholesterol | 38 mg/dL | Standard Deviation 9 |
Secondary
HDL Cholesterol
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | HDL Cholesterol | 34 mg/dL | Standard Deviation 8 |
| Ziprasidone Treatment | HDL Cholesterol | 35 mg/dL | Standard Deviation 5 |
Secondary
LDL Cholesterol
Time frame: 4-5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | LDL Cholesterol | 106 mg/dL | Standard Deviation 29 |
| Ziprasidone Treatment | LDL Cholesterol | 109 mg/dL | Standard Deviation 35 |
Secondary
LDL Cholesterol
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | LDL Cholesterol | 108 mg/dL | Standard Deviation 43 |
| Ziprasidone Treatment | LDL Cholesterol | 106 mg/dL | Standard Deviation 35 |
Secondary
Systolic Blood Pressure
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Systolic Blood Pressure | 118 mm Hg | Standard Deviation 15 |
| Ziprasidone Treatment | Systolic Blood Pressure | 121 mm Hg | Standard Deviation 13 |
Secondary
Systolic Blood Pressure
Time frame: 4-5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Systolic Blood Pressure | 123 mm Hg | Standard Deviation 15 |
| Ziprasidone Treatment | Systolic Blood Pressure | 128 mm Hg | Standard Deviation 15 |
Secondary
Triglycerides
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Triglycerides | 183 mg/dL | Standard Deviation 166 |
| Ziprasidone Treatment | Triglycerides | 227 mg/dL | Standard Deviation 154 |
Secondary
Triglycerides
Time frame: 4-5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stay on Current Antipsychotic | Triglycerides | 154 mg/dL | Standard Deviation 87 |
| Ziprasidone Treatment | Triglycerides | 252 mg/dL | Standard Deviation 179 |