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Treatment of Acute Schizophrenia With Vitamin Therapy

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.
ClinicalTrials.gov Identifier: NCT00140166
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : November 25, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
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

  Show Detailed Description

Study Design

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
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Pyridoxine
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

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
Criteria

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
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): NCT00140166


Locations
Israel
Beersheva Mental Health Center
Beersheva, Israel
Sponsors and Collaborators
Beersheva Mental Health Center
Supported by a Hilton Family Foundation grant to
International Schizophrenia Foundation
Investigators
Principal Investigator: Vladimir Lerner, MD Beersheva Mental Health Center
Study Director: RH Belmaker, MD Ben-Gurion University of the Negev
More Information

Responsible Party: Vladimir Lerner, Ben Gurion University
ClinicalTrials.gov Identifier: NCT00140166     History of Changes
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:
schizophrenia
niacinamide

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Pyridoxine
Pyridoxal
Vitamin B 6
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents