Bipolar Disorder, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
schizophrenia, schizoaffective disorder, bipolar disorder, metabolic syndrome
Brief summary
The objective of this study is to determine the effect of various mood stabilizers (MS) on the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in patients treated with antipsychotic drugs (APDs). Patients will be switched from their current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless clinically contraindicated) for comparison with metabolic levels during treatment with the former medication. The metabolic syndrome is an empirical concept based on extensive evidence that a constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of cancer.
Interventions
DRUGziprasidone vs. aripiprazole
ziprasidone vs. aripiprazole dosed according to package insert
DRUGaripiprazole vs. ziprasidone
aripiprazole vs. ziprasidone dosed according to package insert
Sponsors
National Alliance for Research on Schizophrenia and Depression
Pfizer
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
To be eligible, patients must : * Be male or female, age 18-65 * Be diagnosed with schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria * Be currently receiving antipsychotic drugs (clozapine, haloperidol, olanzapine, quetiapine, or risperidone) (APDs) alone, mood stabilizer(s) (MS) alone, or a combination of the two * Have a history of compliance with the above medication * Have presumptive IRS as indicated by a TG/HDL ratio \> 3.5 on current antipsychotic medication * Be Medicaid eligible or maintain insurance covering requested lab procedures * Be able to provide written informed consent
Exclusion criteria
A patient will be considered ineligible if he/she: * Has a diagnosis other than schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria. * Has a history of noncompliance with prescribed psychiatric medications * Has a TG/HDL ratio \< 3.5 on current medication * Is uninsured or is unable to self-pay potential costs of required lab procedures not covered by insurance. * Is unable to provide written informed consent. * (Females only) Is pregnant, lactating or plans to become pregnant during study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HDL Ratio | 24 weeks from Baseline | change in HDL ratio after medication switch |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aripiprazole aripiprazole (Abilify)
ziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert
aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert | 23 |
| Ziprasidone ziprasidone (Geodon)
aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert | 26 |
| Total | 49 |
Baseline characteristics
| Characteristic | Ziprasidone | Aripiprazole | 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 | 26 Participants | 23 Participants | 49 Participants |
| Age, Continuous | 45.5 years STANDARD_DEVIATION 9.4 | 44.3 years STANDARD_DEVIATION 8.5 | 44.9 years STANDARD_DEVIATION 8.95 |
| Region of Enrollment United States | 26 participants | 23 participants | 49 participants |
| Sex: Female, Male Female | 16 Participants | 13 Participants | 29 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 26 |
| other Total, other adverse events | 1 / 23 | 0 / 26 |
| serious Total, serious adverse events | 0 / 23 | 0 / 26 |
Outcome results
Primary
HDL Ratio
change in HDL ratio after medication switch
Time frame: 24 weeks from Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole | HDL Ratio | Baseline | 39.7 unit of Measure ''g/dL'' | Standard Error 1.6 |
| Aripiprazole | HDL Ratio | 24 weeks | 43.5 unit of Measure ''g/dL'' | Standard Error 2.1 |
| Ziprasidone | HDL Ratio | Baseline | 38.4 unit of Measure ''g/dL'' | Standard Error 1.5 |
| Ziprasidone | HDL Ratio | 24 weeks | 42.3 unit of Measure ''g/dL'' | Standard Error 1.8 |