Vitamin D for Schizophrenia

NCT01759485 | Completed

• 2 other identifiers: GMHC-VITD29-12
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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), 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.

Conditions

Clozapine Resistant Schizophrenia

Keywords

Clozapine; Schizophrenia; Vitamin-D; Treatment-resistant

Outcome Measures

Primary Outcomes (1)

• Change in Positive and Negative Syndrome Scale total score

  Baseline to 8 weeks

Secondary Outcomes (1)

• Change in the MoCA Cognitive composite score

  Baseline to 8 weeks

Other Outcomes (1)

• Change in Positive and Negative Syndrome Scale sub-scores

  Baseline to 8 weeks

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Supplementation of Vitamin D as add-on to the regular anti-psychotic treatment

Drug: Vitamin D3

Placebo

PLACEBO COMPARATOR

Placebo as oral drops once weekly as add-on to the regular anti-psychotic treatment

Drug: placebo

Interventions

Vitamin D3 DRUG

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

Vitamin D

placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• Age 18-65 years
• Diagnosis of schizophrenia according to DSM-IV-TR criteria, as confirmed by two senior psychiatrists
• Total PANSS score \> 70
• CGI-S \> 3
• Clozapine treatment for at least 18 weeks
• Vitamin D deficiency: plasma 25-OH-Vitamin D \<75 nmol/L (20-30 ng/mL)
• Able to consume oral drops of vitamin-D
• Able to sign informed consent

You may not qualify if:

• Mental retardation
• Organic brain disease
• Known parathyroid disorder
• Inborn/acquired vitamin D metabolism disorders
• Patients already treated with vitamin D supplementation

Sponsors & Collaborators

• Geha Mental Health Center: lead

Study Sites (1)

Geha Mental Health Center

Petah Tikva, 45000, Israel

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Psychiatrist

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: January 3, 2013
• Study Start: May 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: February 28, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

IL (1)