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
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