Examining Risk Factors for Atypical Antipsychotic Metabolic Side Effects
Schizophrenia
About this trial
This is an interventional other trial for Schizophrenia focused on measuring Antipsychotic, Metabolic Syndrome, Insulin Resistance, Endothelial Function
Eligibility Criteria
Inclusion Criteria for Phase 1:
- DSM-IV diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or psychosis not otherwise specified
- Treatment with one of the following atypical antipsychotics (AAPs) for at least 6 months: clozapine, olanzapine, risperidone, quetiapine, aripiprazole, or ziprasidone
Inclusion Criteria for Phase 2:
- Previous participation in Phase 1 pharmacogenomic study
- Meets metabolic syndrome criteria
- No medication changes for 6 months, including antipsychotic medication changes and changes in any other medications related to treating metabolic syndrome, diabetes, hypertension, or hyperlipidemia
Exclusion Criteria for Phases 1 and 2:
- Presence of any serious medical condition that would significantly affect weight changes, such as neoplastic or thyroid disease
- Diagnosis of active substance dependence or use of illicit substances within the past month
- History of type 2 diabetes mellitus prior to AAP use
- Past history of or currently has pernicious, aplastic, or normocytic anemia with a B12 deficiency
Inclusion criteria for Phase 2B:
- At least 18 years old and presence of a DSM-IV diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or psychosis NOS
- Receiving atypical antipsychotic medication for at least 6 months
- Currently meet ≥ 2 of the NCEP-ATP-III criteria for metabolic syndrome
- No medication changes within the last two months
- Vitamin B12 levels within normal laboratory levels
- No illicit drug use in the past month
Exclusion Criteria for Phase 2B
- Inability to give informed consent or unwillingness to participate
- Presence of any serious medical conditions that would significantly affect weight changes (i.e. neoplastic or uncontrolled thyroid disease)
- Blood pressure lower than 90/60 mmHg
- History of Type 2 Diabetes Mellitus prior to AAP use
- History of hypersensitivity or allergic reaction to folic acid or any of the product ingredients
- Current pregnancy or nursing
- Current substance dependence diagnosis
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Folate
Placebo
During Phase 1, participants will undergo screening for metabolic syndrome and have genetic makeup, body size, and endothelial functioning measured. During Phase 2, participants will receive daily folic acid as a treatment for metabolic syndrome. Phase 2B participants will receive either daily folic acid or placebo as a treatment for metabolic syndrome.
During Phase 1, participants will undergo screening for metabolic syndrome and have genetic makeup, body size, and endothelial functioning measured. During Phase 2, participants will receive daily folic acid as a treatment for metabolic syndrome. Phase 2B participants will receive either daily folic acid or placebo as a treatment for metabolic syndrome.