Examining Risk Factors for Atypical Antipsychotic Metabolic Side Effects

NCT00815854 | Completed DMC

• 3 other identifiers: R01MH082784R01MH082784-01DATR A5-ETSE
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine possible causes of metabolic side effects in people taking atypical antipsychotic (AAP) medications.

Conditions

Schizophrenia

Keywords

Antipsychotic; Metabolic Syndrome; Insulin Resistance; Endothelial Function

Outcome Measures

Primary Outcomes (1)

• Endothelial functioning

  Using the EndoPAT machine (Itamar) we will measure the Reactive hyperemia index (RHI)

  Measured at baseline and after 3 months, and then at a two month follow up visit

Secondary Outcomes (1)

• metabolic syndrome

  measured at baseline, endpoint, and follow up

Study Arms (2)

Folate

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Folic Acid DIETARY_SUPPLEMENT

5 mg of folic acid taken daily for 3 months in an open label fashion

Also known as: Folate

Folate

Placebo OTHER

Subjects may receive placebo (a sugar pill) for 4 months

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Schizophrenia; Metabolic Syndrome; Insulin Resistance

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vicki L. Ellingrod, PharmD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: December 31, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: June 21, 2019

Record last verified: 2019-06

Locations

US (1)