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Treatment of Acute Schizophrenia With Vitamin Therapy

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ClinicalTrials.gov Identifier: NCT00140166
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : November 25, 2009
Supported by a Hilton Family Foundation grant to
International Schizophrenia Foundation
Information provided by:
Beersheva Mental Health Center

Brief Summary:
Controlled studies using the orthomolecular approach have been few (Deutsch, Ananth, & Ban, 1977). Those that were done were performed in chronic schizophrenia or in populations that included bipolar and schizoaffective patients. Both of these diagnostic groups are not today considered to benefit from the orthomolecular approach. Moreover, some negative studies of high-dose niacin were done in patients who were not otherwise given general counseling for good diet as described above. Therefore, this proposal is to study in a controlled manner carefully defined first onset schizophrenic patients using the protocol advocated by Osmond and Hoffer (1962). Patients can enter the study if they have been ill less than 1 year and are in their first hospitalization.

Condition or disease Intervention/treatment Phase
Acute Schizophrenia Drug: niacinamide Drug: pyridoxine Drug: ascorbate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Treatment of Acute Schizophrenia With High Dose Niacinmide Plus Ascorbate Plus Pyridoxine Plus Centrum Forte vs. Centrum Forte Only as an Add-On to Risperidone and Dietary Counseling
Study Start Date : July 2005
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  1. Brief Psychiatric Rating Scale
  2. Global Clinical Assessment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 18-30
  • schizophrenia or schizophreniform disorder
  • first psychiatric admission and first episode of psychosis
  • mentally ill for less than one year

Exclusion Criteria:

  • alcohol or drug abuse in last 6 months
  • significant physical illness
  • mental retardation

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): NCT00140166

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Beersheva Mental Health Center
Beersheva, Israel
Sponsors and Collaborators
Beersheva Mental Health Center
Supported by a Hilton Family Foundation grant to
International Schizophrenia Foundation
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Principal Investigator: Vladimir Lerner, MD Beersheva Mental Health Center
Study Director: RH Belmaker, MD Ben-Gurion University of the Negev
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Responsible Party: Vladimir Lerner, Ben Gurion University
ClinicalTrials.gov Identifier: NCT00140166    
Other Study ID Numbers: BMHC-3996
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009
Keywords provided by Beersheva Mental Health Center:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Nicotinic Acids
Vitamin B Complex
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents