Examining Risk Factors for Atypical Antipsychotic Metabolic Side Effects
Dietary Supplement: Folic Acid
Dietary Supplement: folic acid
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
|Official Title:||Folate Pharmacogenomics and Risk of Atypical Antipsychotic Metabolic Side Effects|
- Endothelial functioning [ Time Frame: Measured at baseline and after 3 months, and then at a two month follow up visit ] [ Designated as safety issue: No ]
- metabolic syndrome [ Time Frame: measured at baseline, endpoint, and follow up ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
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.
Dietary Supplement: Folic Acid
5 mg of folic acid taken daily for 3 months in an open label fashion
Other Name: FolateDietary Supplement: folic acid
subjects may receive folic acid 5mg daily for 4 monthsOther: Placebo
Subjects may receive placebo (a sugar pill) for 4 months
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, second generation antipsychotic medications that effectively treat psychotic symptoms but that also have severe side effects. One side effect is an increased risk of metabolic syndrome, which is a cluster of conditions that together increase the risk of heart disease, stroke, type 2 diabetes, and endothelial dysfunction—dysfunction of the cells that line the inner surface of blood cells. Schizophrenic patients taking atypical antipsychotics are more than twice as likely as the general population to experience metabolic syndrome. Certain genetic variants associated with folate metabolism, as well as low dietary folate, may lead to the development of metabolic syndrome and its associated diseases. These factors have been studied in the general population, but not in a group of schizophrenic patients taking antipsychotics. This study will examine the relationship among folic acid, variants in the gene methylenetetrahydrofolate reductase, and metabolic syndrome and its associated diseases in people with schizophrenia who are taking atypical antipsychotics. The study will also evaluate the use of folic acid supplementation for treating metabolic syndrome in this population.
Participation in this study will involve two phases. The first phase will involve recruitment, screening, and testing of participants taking antipsychotics and will last 4 years. During this phase, participants will attend one study visit in which they will undergo a screening for metabolic syndrome and have the following measured: endothelial functioning, body size, diet, physical activity, medication history, and genetic makeup. Participants who have metabolic syndrome will be invited to participate in Phase 2.
Phase 2 will run concurrently with Phase 1, but will extend to 5 years, in order to give all participants an opportunity to continue from one phase to the next if they meet entry criteria. Participants in Phase 2 will attend four study visits over the course of 3 months: one at the beginning of the phase and one after each month of the study. After the first study visit, participants will be given folic acid to take daily for the 3 months. At each study visit, participants will be asked about thoughts, illness, functioning, diet, medication side effects, recent medication history, smoking history, alcohol intake, and exercise habits. On the first and last visits, participants will undergo additional tests of genetics, blood hormone levels, and blood vessel functioning, and additional measurements will be made of height, weight, vital signs, and body size. The Phase 2 study is now inactive.
Phase 2B is active and currently recruiting participants. This is a randomized, placebo controlled study of folate supplementation. Participants in phase 2B will attend 6 study visits over the course of 6 months. At the first study visit they will be randomized to either folic acid 5mg daily for 4 months or placebo. This 4 month period is followed by a 2 month follow up visit, when no supplementation is given. At each study visit, participants will be asked about thoughts, illness, functioning, diet, medication side effects, recent medication history, smoking history, alcohol intake, and exercise habits. On the first and last visits, participants will undergo additional tests of genetics, blood hormone levels, and blood vessel functioning, and additional measurements will be made of height, weight, vital signs, and body size.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815854
|Contact: Vicki L. Ellingrod, PharmDfirstname.lastname@example.org|
|Contact: Zarina Kraal, BS, MSemail@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator: Vicki L. Ellingrod, PharmD|
|Principal Investigator:||Vicki L. Ellingrod, PharmD||University of Michigan|