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Vitamin D for Schizophrenia

Information source: Geha Mental Health Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clozapine Resistant Schizophrenia

Intervention: Vitamin D3 (Drug); placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Geha Mental Health Center

Overall contact:
Amir Krivoy, MD, Phone: 972-3-9258220, Email: akrivoy@clalit.org.il

Summary

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, MCCB), 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.

Clinical Details

Official title: Vitamin D Supplementation as Adjunct to Clozapine-treated Chronic Schizophrenia Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Positive and Negative Syndrome Scale total score

Secondary outcome: change in the MATRICS Consensus Cognitive Battery composite score

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Males and females 2. Age 18-65 years 3. Diagnosis of schizophrenia according to DSM-IV-TR criteria, as confirmed by two senior psychiatrists 4. Total PANSS score > 70 5. CGI-S > 3 6. Clozapine treatment for at least 18 weeks 7. Vitamin D deficiency: plasma 25-OH-Vitamin D <100 nmol/L (20-40 ng/mL) 8. Able to consume oral drops of vitamin-D 9. Able to sign informed consent Exclusion Criteria: 1. Mental retardation 2. Organic brain disease 3. Known parathyroid disorder 4. Inborn/acquired vitamin D metabolism disorders 5. Patients already treated with vitamin D supplementation

Locations and Contacts

Amir Krivoy, MD, Phone: 972-3-9258220, Email: akrivoy@clalit.org.il

Geha Mental Health Center, Petach-Tikva 45000, Israel; Recruiting
Roy Onn, MD, Phone: 972-3-9258220, Email: ronn@clalit.org.il
Roy Onn, MD, Principal Investigator
Additional Information

Starting date: January 2013
Last updated: August 20, 2013

Page last updated: August 20, 2015

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