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Vitamin D for Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01759485
First Posted: January 3, 2013
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amir Krivoy, Geha Mental Health Center
  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), 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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Amir Krivoy, Geha Mental Health Center:

Primary Outcome Measures:
  • Change in Positive and Negative Syndrome Scale total score [ Time Frame: Baseline to 8 weeks ]

Secondary Outcome Measures:
  • Change in the MoCA Cognitive composite score [ Time Frame: Baseline to 8 weeks ]

Other Outcome Measures:
  • Change in Positive and Negative Syndrome Scale sub-scores [ Time Frame: Baseline to 8 weeks ]

Enrollment: 47
Actual Study Start Date: May 2014
Study Completion Date: February 28, 2017
Primary Completion Date: September 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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 <75 nmol/L (20-30 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759485


Locations
Israel
Geha Mental Health Center
Petach-Tikva, Israel, 45000
Sponsors and Collaborators
Geha Mental Health Center
  More Information

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 ( Other Identifier: GMHC )
First Submitted: December 4, 2012
First Posted: January 3, 2013
Last Update Posted: April 13, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Clozapine
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents