Background: Despite improvements in medications, treatment delivery and rehabilitation,
schizophrenia outcomes remain suboptimal. There are a proportion of 30-40%
treatment-resistant schizophrenia patients. Multiple lines of evidence suggest that vitamin D
is a neuro-active steroid that acts on brain development, leading to alterations in brain
neurochemistry and adult brain function. Early deficiencies have been linked with
neuropsychiatric disorders, such as schizophrenia, and adult deficiencies have been
associated with adverse brain outcomes, including Parkinson's disease, Alzheimer's disease,
depression and cognitive decline. Ecological studies support a potential role for vitamin D
in schizophrenia. These data include studies that have explored the association between
schizophrenia and winter/spring birth and also the apparent increased incidence and
prevalence of schizophrenia at higher latitudes. Objective: To evaluate the effect of
vitamin-D supplementation on the mental state of clozapine-treated chronic schizophrenia
patients, and the relation of disease severity to serum vitamin D levels. Methods: the
investigators will use a prospective, interventional, longitudinal, double blinded,
placebo-controlled, randomized design. The investigators will recruit 50 clozapine-treated
chronic schizophrenia patients, with low level of serum vitamin-D, that will be randomly
assigned (1:1 ratio) to receive either weekly oral drops of vitamin D (Cholecalciferol) or
oral drops of placebo for 8 weeks follow-up. Repeated assessments will include: clinical
severity scales (PANSS, CGI), side effects (SAS, BARS, clozapine side effects), cognitive
(MoCA), metabolic parameters and laboratory data. Patients who were assigned to placebo will
be supplemented with vitamin D after the 8 weeks period, and then will be assessed again with
the same protocol of vitamin D treated patients. All participants will be assessed again
after 24 weeks after vitamin D initiation. Analysis: the investigators will use on-way ANOVA
with repeated measures for comparison of vitamin D and control groups. The investigators will
apply intention to treat and LOCF.
Phase:
N/A
Details
Lead Sponsor:
Geha Mental Health Center
Treatments:
Cholecalciferol Clozapine Ergocalciferols Vitamin D Vitamins