Vitamin D for Schizophrenia
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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 |
- Change in Positive and Negative Syndrome Scale total score [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
- change in the MATRICS Consensus Cognitive Battery composite score [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- 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 <100 nmol/L (20-40 ng/mL)
- Able to consume oral drops of vitamin-D
- Able to sign informed consent
Exclusion Criteria:
- Mental retardation
- Organic brain disease
- Known parathyroid disorder
- Inborn/acquired vitamin D metabolism disorders
- Patients already treated with vitamin D supplementation
Contacts and Locations| Contact: Amir Krivoy, MD | 972-3-9258220 | akrivoy@clalit.org.il |
| Israel | |
| Geha Mental Health Center | Not yet recruiting |
| Petach-Tikva, Israel, 45000 | |
| Contact: Roy Onn, MD 972-3-9258220 ronn@clalit.org.il | |
| Principal Investigator: Roy Onn, MD | |
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: | January 5, 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 Cholecalciferol Vitamin D Ergocalciferols Vitamins Clozapine Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs GABA Antagonists GABA Agents |
ClinicalTrials.gov processed this record on May 19, 2013