Treatment of Acute Schizophrenia With Vitamin Therapy - Full Text View

Sponsors and Collaborators:	Beersheva Mental Health Center Supported by a Hilton Family Foundation grant to International Schizophrenia Foundation
Information provided by:	Beersheva Mental Health Center
ClinicalTrials.gov Identifier:	NCT00140166

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 IV

MedlinePlus related topics: Mental Health Schizophrenia

Drug Information available for: Vitamin B 6 5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride Pyridoxine Risperidone Niacinamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
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

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

Responsible Party:	Ben Gurion University ( Vladimir Lerner )
Study ID Numbers:	BMHC-3996
Study First Received:	August 31, 2005
Last Updated:	May 26, 2008
ClinicalTrials.gov Identifier:	NCT00140166
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Beersheva Mental Health Center:

schizophrenia
niacinamide

Study placed in the following topic categories:

Schizophrenia
Niacinamide
Mental Disorders
Risperidone

Pyridoxine
Psychotic Disorders
Vitamin B 6
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Vitamin B Complex
Growth Substances
Vitamins

Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009