Bipolar Disorder, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
schizophrenia, schizoaffective disorder, bipolar disorder, metabolic syndrome
Brief summary
The primary goal of this study is to examine the triglyceride/high-density lipoprotein (TG/HDL) ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.
Detailed description
The primary goal of this study is to examine the triglyceride/high-density lipoprotein (TG/HDL) ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder. The secondary goal is to identify those subjects in the top tertile for the highest risk of ischemic heart disease (IHD) as defined by TG/HDL ratios (\>\>3.5) and ischemic EKG changes with and without clinical ischemia, e.g. angina and to see if these risk factors can be reduced or reversed by a change of antipsychotic medication, dietary counseling, enrollment into available exercise groups, etc.
Interventions
active drug given daily as per package insert according to standard clinical care for twelve month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.
active medication will be given daily as per package insert according to standard clinical care for the twelve month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.
Sponsors
National Alliance for Research on Schizophrenia and Depression
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, a patient must : * Be male or female, between 18-65. * Have a diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual (DSM-IV) criteria * Have TG/HDL ratios (\>\>3.5) and ischemic EKG changes with and without clinical ischemia, e.g. angina * Be treated for a minimum of six months with one of six oral antipsychotic medications: clozapine, haloperidol, olanzapine, quetiapine, risperidone and ziprasidone * Be willing to change current antipsychotic medication to that chosen by the principal investigator * Have a history of compliance with the above 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 |
|---|---|
| Triglyceride/High-density Lipoprotein (TG/HDL) Ratio | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Weight | 24 weeks |
| Body Mass Index (BMI) | 24 weeks |
| Cholesterol | 24 weeks |
| High-Density Lipoprotein (HDL) | 24 weeks |
| Triglyceride (TG) | 24 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aripiprazole (Abilify) aripiprazole (Abilify): active drug given daily as per package insert according to standard clinical care for the twelve-month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication. | 25 |
| Ziprasidone (Geodon) ziprasidone (Geodon): active medication will be given daily as per package insert according to standard clinical care for the twelve-month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication. | 23 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 2 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 5 |
Baseline characteristics
| Characteristic | Ziprasidone (Geodon) | Aripiprazole (Abilify) | Total |
|---|---|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 9.4 | 44.3 years STANDARD_DEVIATION 8.5 | 44.9 years STANDARD_DEVIATION 8.9 |
| Diagnosis of schizophrenia (SCH) and schizoaffective disorder (SCHAF) or bipolar disorder number bipolar disorder | 14 Participants | 11 Participants | 25 Participants |
| Diagnosis of schizophrenia (SCH) and schizoaffective disorder (SCHAF) or bipolar disorder number schizophrenia (SCH) or schizoaffective disorder (SCHAF) | 9 Participants | 14 Participants | 23 Participants |
| Drug taken prior to enrollment Mood stabilizer only | 2 Participants | 1 Participants | 3 Participants |
| Drug taken prior to enrollment Olazapine | 4 Participants | 4 Participants | 8 Participants |
| Drug taken prior to enrollment Quetiapine | 9 Participants | 10 Participants | 19 Participants |
| Drug taken prior to enrollment Risperidone | 7 Participants | 8 Participants | 15 Participants |
| Drug taken prior to enrollment Typical neuroleptics | 1 Participants | 2 Participants | 3 Participants |
| Hypertension, number Participants with hypertension | 3 Participants | 13 Participants | 16 Participants |
| Hypertension, number Participants without hypertension | 20 Participants | 12 Participants | 32 Participants |
| Positive and Negative Syndrome Scale (PANSS) Cognitive Score | 6.6 units on a scale STANDARD_DEVIATION 0.4 | 6.7 units on a scale STANDARD_DEVIATION 0.4 | 6.65 units on a scale STANDARD_DEVIATION 0.4 |
| Positive and Negative Syndrome Scale (PANSS) Negative Score | 15.2 units on a scale STANDARD_DEVIATION 0.6 | 15.3 units on a scale STANDARD_DEVIATION 0.7 | 15.25 units on a scale STANDARD_DEVIATION 0.65 |
| Positive and Negative Syndrome Scale (PANSS) Positive Score | 14.2 units on a scale STANDARD_DEVIATION 0.7 | 14.2 units on a scale STANDARD_DEVIATION 0.7 | 14.2 units on a scale STANDARD_DEVIATION 0.7 |
| Positive and Negative Syndrome Scale (PANSS) Total Score | 61.0 units on a scale STANDARD_DEVIATION 2.2 | 61.3 units on a scale STANDARD_DEVIATION 2.2 | 61.15 units on a scale STANDARD_DEVIATION 2.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex/Gender, Customized Self-Reported Gender Female | 13 Participants | 16 Participants | 29 Participants |
| Sex/Gender, Customized Self-Reported Gender Male | 10 Participants | 9 Participants | 19 Participants |
| Type 2 Diabetes, number Participants without Type 2 Diabetes | 18 Participants | 21 Participants | 39 Participants |
| Type 2 Diabetes, number Participants with Type 2 Diabetes | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 23 |
| other Total, other adverse events | 0 / 25 | 0 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 23 |
Outcome results
Primary
Triglyceride/High-density Lipoprotein (TG/HDL) Ratio
Time frame: 24 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Abilify) | Triglyceride/High-density Lipoprotein (TG/HDL) Ratio | Baseline | 8.1 (mg/dL)/(mg/dL) | Standard Error 0.7 |
| Aripiprazole (Abilify) | Triglyceride/High-density Lipoprotein (TG/HDL) Ratio | 6 weeks | 4.9 (mg/dL)/(mg/dL) | Standard Error 0.7 |
| Aripiprazole (Abilify) | Triglyceride/High-density Lipoprotein (TG/HDL) Ratio | 12 weeks | 4.8 (mg/dL)/(mg/dL) | Standard Error 0.7 |
| Aripiprazole (Abilify) | Triglyceride/High-density Lipoprotein (TG/HDL) Ratio | 24 weeks | 5.7 (mg/dL)/(mg/dL) | Standard Error 0.9 |
| Ziprasidone (Geodon) | Triglyceride/High-density Lipoprotein (TG/HDL) Ratio | 24 weeks | 5.2 (mg/dL)/(mg/dL) | Standard Error 0.7 |
| Ziprasidone (Geodon) | Triglyceride/High-density Lipoprotein (TG/HDL) Ratio | Baseline | 8.2 (mg/dL)/(mg/dL) | Standard Error 0.6 |
| Ziprasidone (Geodon) | Triglyceride/High-density Lipoprotein (TG/HDL) Ratio | 12 weeks | 5.6 (mg/dL)/(mg/dL) | Standard Error 0.7 |
| Ziprasidone (Geodon) | Triglyceride/High-density Lipoprotein (TG/HDL) Ratio | 6 weeks | 4.7 (mg/dL)/(mg/dL) | Standard Error 0.7 |
Secondary
Body Mass Index (BMI)
Time frame: 24 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Abilify) | Body Mass Index (BMI) | Baseline | 35.5 kg/m^2 | Standard Error 0.4 |
| Aripiprazole (Abilify) | Body Mass Index (BMI) | 6 weeks | 34.7 kg/m^2 | Standard Error 0.4 |
| Aripiprazole (Abilify) | Body Mass Index (BMI) | 12 weeks | 34.6 kg/m^2 | Standard Error 0.4 |
| Aripiprazole (Abilify) | Body Mass Index (BMI) | 24 weeks | 34.4 kg/m^2 | Standard Error 0.5 |
| Ziprasidone (Geodon) | Body Mass Index (BMI) | 24 weeks | 33.9 kg/m^2 | Standard Error 0.4 |
| Ziprasidone (Geodon) | Body Mass Index (BMI) | Baseline | 35.5 kg/m^2 | Standard Error 0.4 |
| Ziprasidone (Geodon) | Body Mass Index (BMI) | 12 weeks | 34.3 kg/m^2 | Standard Error 0.5 |
| Ziprasidone (Geodon) | Body Mass Index (BMI) | 6 weeks | 34.1 kg/m^2 | Standard Error 0.4 |
Secondary
Cholesterol
Time frame: 24 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Abilify) | Cholesterol | Baseline | 210.4 mg/DL | Standard Error 8.8 |
| Aripiprazole (Abilify) | Cholesterol | 6 Weeks | 193.0 mg/DL | Standard Error 9.1 |
| Aripiprazole (Abilify) | Cholesterol | 12 Weeks | 209.2 mg/DL | Standard Error 9.4 |
| Aripiprazole (Abilify) | Cholesterol | 24 Weeks | 197.7 mg/DL | Standard Error 10.3 |
| Ziprasidone (Geodon) | Cholesterol | 24 Weeks | 85.9 mg/DL | Standard Error 9.3 |
| Ziprasidone (Geodon) | Cholesterol | Baseline | 211.7 mg/DL | Standard Error 7.9 |
| Ziprasidone (Geodon) | Cholesterol | 12 Weeks | 193.2 mg/DL | Standard Error 9 |
| Ziprasidone (Geodon) | Cholesterol | 6 Weeks | 203.7 mg/DL | Standard Error 8.4 |
Secondary
High-Density Lipoprotein (HDL)
Time frame: 24 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Abilify) | High-Density Lipoprotein (HDL) | Baseline | 39.7 mg/dL | Standard Error 1.6 |
| Aripiprazole (Abilify) | High-Density Lipoprotein (HDL) | 6 Weeks | 42.0 mg/dL | Standard Error 1.7 |
| Aripiprazole (Abilify) | High-Density Lipoprotein (HDL) | 12 Weeks | 43.5 mg/dL | Standard Error 1.8 |
| Aripiprazole (Abilify) | High-Density Lipoprotein (HDL) | 24 Weeks | 43.5 mg/dL | Standard Error 2.1 |
| Ziprasidone (Geodon) | High-Density Lipoprotein (HDL) | 24 Weeks | 42.3 mg/dL | Standard Error 1.8 |
| Ziprasidone (Geodon) | High-Density Lipoprotein (HDL) | Baseline | 38.4 mg/dL | Standard Error 1.5 |
| Ziprasidone (Geodon) | High-Density Lipoprotein (HDL) | 12 Weeks | 45.0 mg/dL | Standard Error 1.7 |
| Ziprasidone (Geodon) | High-Density Lipoprotein (HDL) | 6 Weeks | 45.0 mg/dL | Standard Error 1.6 |
Secondary
Triglyceride (TG)
Time frame: 24 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Abilify) | Triglyceride (TG) | 6 Weeks | 204.3 mg/dL | Standard Error 29.7 |
| Aripiprazole (Abilify) | Triglyceride (TG) | Baseline | 306.1 mg/dL | Standard Error 27.1 |
| Aripiprazole (Abilify) | Triglyceride (TG) | 24 Weeks | 238.7 mg/dL | Standard Error 36.3 |
| Aripiprazole (Abilify) | Triglyceride (TG) | 12 Weeks | 198.8 mg/dL | Standard Error 29.7 |
| Ziprasidone (Geodon) | Triglyceride (TG) | 24 Weeks | 208.1 mg/dL | Standard Error 30.8 |
| Ziprasidone (Geodon) | Triglyceride (TG) | 6 Weeks | 202.5 mg/dL | Standard Error 27.1 |
| Ziprasidone (Geodon) | Triglyceride (TG) | 12 Weeks | 228.5 mg/dL | Standard Error 28.8 |
| Ziprasidone (Geodon) | Triglyceride (TG) | Baseline | 303.5 mg/dL | Standard Error 25.1 |
Secondary
Weight
Time frame: 24 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Abilify) | Weight | Baseline | 216.8 lbs | Standard Error 2.4 |
| Aripiprazole (Abilify) | Weight | 24 weeks | 210.9 lbs | Standard Error 3 |
| Aripiprazole (Abilify) | Weight | 6 weeks | 211.8 lbs | Standard Error 2.5 |
| Aripiprazole (Abilify) | Weight | 12 weeks | 211.2 lbs | Standard Error 2.6 |
| Ziprasidone (Geodon) | Weight | 12 weeks | 209.4 lbs | Standard Error 2.5 |
| Ziprasidone (Geodon) | Weight | 6 weeks | 208.8 lbs | Standard Error 2.3 |
| Ziprasidone (Geodon) | Weight | 24 weeks | 207.1 lbs | Standard Error 2.5 |
| Ziprasidone (Geodon) | Weight | Baseline | 216.7 lbs | Standard Error 2.2 |