Status:
COMPLETED
Examining Risk Factors for Atypical Antipsychotic Metabolic Side Effects
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This study will examine possible causes of metabolic side effects in people taking atypical antipsychotic (AAP) medications.
Detailed Description
Antipsychotic medications are used to treat some of the most severe symptoms of mental illness, such as hallucinations and irrational outbursts. Atypical antipsychotics (AAPs) are a group of newer, se...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00815854
Start Date
October 1 2008
End Date
May 1 2019
Last Update
June 21 2019
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109