The Influence of Vitamin D on Atypical Antipsychotic-induced Weight Gain

Completed

Conditions studied: Schizophrenia, Metabolic Syndrome, Vitamin D Deficiency

In brief

Schizophrenia and bipolar disorders are major public health problems. The second generation anti-psychotic drugs have efficacy for both positive and negative symptoms and a favorable risk profile as far as movement disorders. However, these drugs are associated with clinically significant weight gain and metabolic effects. The underlying mechanisms of these side effects are unclear, however in our preliminary studies with schizophrenic patients on atypical anti-psychotic drugs, we found that weight gain and vitamin D deficiency was present in about 50% of this population. Given the considerable heterogeneity among the patients on atypical anti-psychotics and potential for weight gain in vitamin D-deficient states, we propose that patients with schizophrenia who gain weight on atypical antipsychotic medications are vitamin D-deficient. This hypothesis will be tested in patients with schizophrenia receiving second-generation anti-psychotic drugs for a minimum duration of 4 months. Specific Aim: We predict that the patients with schizophrenia, who gain weight with antipsychotic treatment, are vitamin D-deficient compared to the patients who do not gain weight. We will examine circulating levels of serum 25(OH)D, mRNA transcripts and protein expression of vitamin D receptor (VDR) and the enzymes, CYP24A and CYP27B, in the white blood cells of the subjects and correlate with BMI and the blood levels of leptin and adiponectin.

Key facts

Study ID

NCT02281162

Run by

Creighton University

People needed

20

Starts

2014-11-01

Expected to finish

2015-09-01

Last updated by the study team

2016-01-08

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• • Men and women with a DSM-IV clinical diagnosis of Schizophrenia, Schizoaffective or Bipolar disorder
• 21 to 65 years of age; male and female
• A willingness and ability to provide signed informed consent
• The subject should have been on quetiapine 100 mg or more for more than 12 weeks.

You may not qualify if…

• Pregnant women
• Subjects considered at high suicide risk based on the MINI Suicidality Module (> 17 points)
• Unstable general medical condition or serious illness (e.g. death or hospitalization is anticipated within one year), poor kidney function or liver function (defined as laboratory values ≥ three times the upper limit of the normal), and seizure disorders except for childhood seizure disorders
• Concurrent therapy with certain psychotropics is permitted, provided that the medication and dose have been stable for the past 90 days
• Patients on concomitant treatment with clozapine and olanzapine are not permitted.
• Patients on immunosuppressant medications or any orexigenic or anorexigenic drug
• Patients on concomitant treatment with amphetamines and/ or methylphenidate
• History of hypothyroidism or thyroxine therapy
• Patients with a known condition or undergoing therapeutic measures that affects weight, including but not limited to: eating disorder, type I diabetes, hyperthyroidism, thyroxine therapy, Topamax therapy, and infectious diseases, such as HIV, hepatitis B, and hepatitis C
• Active supplementation of vitamin D within the last 3 months

Where it is running

• Alegent Creighton Clinic - Psychiatric Associates (Dodge Street) — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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