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Treatment of Acute Schizophrenia With Vitamin Therapy

This study has been completed.
Sponsor:
Collaborators:
Supported by a Hilton Family Foundation grant to
International Schizophrenia Foundation
Information provided by:
Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
NCT00140166
First received: August 31, 2005
Last updated: November 23, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Acute Schizophrenia
 Drug: niacinamide
Drug: pyridoxine
Drug: ascorbate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:
  • Brief Psychiatric Rating Scale
  • Global Clinical Assessment

Estimated Enrollment: 55
Study Start Date: July 2005
Study Completion Date: May 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Vladimir Lerner, Ben Gurion University
ClinicalTrials.gov Identifier: NCT00140166     History of Changes
Other Study ID Numbers: BMHC-3996
Study First Received: August 31, 2005
Last Updated: November 23, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Beersheva Mental Health Center:
schizophrenia
niacinamide

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

ClinicalTrials.gov processed this record on May 22, 2013