Vitamin D for Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Geha Mental Health Center
Sponsor:
Information provided by (Responsible Party):
Amir Krivoy, Geha Mental Health Center
ClinicalTrials.gov Identifier:
NCT01759485
First received: December 4, 2012
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Clozapine Resistant Schizophrenia
Drug: Vitamin D3
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation as Adjunct to Clozapine-treated Chronic Schizophrenia Patients

Resource links provided by NLM:


Further study details as provided by Geha Mental Health Center:

Primary Outcome Measures:
  • Change in Positive and Negative Syndrome Scale total score [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in the MATRICS Consensus Cognitive Battery composite score [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in Positive and Negative Syndrome Scale sub-scores [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D
Supplementation of Vitamin D as add-on to the regular anti-psychotic treatment
Drug: Vitamin D3
once weekly oral drops preparation at a daily dose of 2000 IU X 7 = 14,000 IU per week (about 60 drops each week).
Other Name: Cholecalciferol
Placebo Comparator: Placebo
Placebo as oral drops once weekly as add-on to the regular anti-psychotic treatment
Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759485

Contacts
Contact: Amir Krivoy, MD 972-3-9258220 akrivoy@clalit.org.il

Locations
Israel
Geha Mental Health Center Recruiting
Petach-Tikva, Israel, 45000
Contact: Roy Onn, MD    972-3-9258220    ronn@clalit.org.il   
Principal Investigator: Roy Onn, MD         
Sponsors and Collaborators
Geha Mental Health Center
  More Information

No publications provided

Responsible Party: Amir Krivoy, Senior Psychiatrist, Geha Mental Health Center
ClinicalTrials.gov Identifier: NCT01759485     History of Changes
Other Study ID Numbers: GMHC-VITD, 29-12
Study First Received: December 4, 2012
Last Updated: August 20, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Geha Mental Health Center:
Clozapine
Schizophrenia
Vitamin-D
Treatment-resistant

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014