An interventional study of Vitamin D3 and placebo in Clozapine Resistant Schizophrenia, sponsored by Geha Mental Health Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-13.
Sponsored by Geha Mental Health Center · Not applicable, Interventional, and Treatment
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.
3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's enrollment of 47 is below the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Geha Mental Health Center is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Supplementation of Vitamin D as add-on to the regular anti-psychotic treatment
Drug: Vitamin D3
Placebo as oral drops once weekly as add-on to the regular anti-psychotic treatment
Drug: placebo
once weekly oral drops preparation at a daily dose of 2000 IU X 7 = 14,000 IU per week (about 60 drops each week).
Also known as: Cholecalciferol
Change in Positive and Negative Syndrome Scale total score
Time frame: Baseline to 8 weeks
Change in the MoCA Cognitive composite score
Time frame: Baseline to 8 weeks
Change in Positive and Negative Syndrome Scale sub-scores
Time frame: Baseline to 8 weeks
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Geha Mental Health Center