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

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. Our Beersheba Mental Health Center is the only hospitalization facility for Southern Israel, population of half a million. There about 2 thousand admissions to our hospital yearly and of those there are over 100 admissions with a diagnosis of schizophrenia or schizophreniform disorder for whom this is the first lifetime admission to hospital and their first episode of psychosis.

Methods Study I - Open Pilot The pilot study will be carried out exactly as below, except without a control group. Results from the pilot will be evaluated before continuing to the controlled study, and protocol modifications presented to the Helsinki Committee if necessary. Ten patients will be studied in this open pilot study.

Study II - Controlled Study, Not Blind Inclusion and exclusion criteria Patients can be accepted to the study age 18-30, if admitting diagnosis after review by the study coordinator is schizophrenia or schizophreniform disorder by DSM-IV. Since the diagnosis of schizophrenia may be difficult in the early stages of acute psychotic disease, cases in which the clinical diagnosis is consistent with and suspicious of schizophrenia (and inconsistent with bipolar disorder) even if they do not fulfill all the diagnostic criteria in DSM-IV will be accepted. Patients with alcohol or drug abuse in the last 6 months will be excluded. Patients with significant physical illness including peptic ulcer, or a history of hepatitis or baseline abnormal liver function tests will be excluded. Patients with mental retardation will be excluded. Baseline screening will be done for liver function (including AST, bilirubin, alkaline phosphatase and LDH) and blood glucose and then repeated after 6 weeks. Elevations of AST over three fold will lead to dropping patient from study. Patients who are unlikely to be able to continue in the study as outpatients will be excluded. Patients will be admitted to study only if this is their first lifetime psychiatric admission and their first episode of psychosis and only if history supports that they have been mentally ill for less than one year.

Procedure Patients who enter the program will be treated with risperidone, 2-8mg daily at physician's discretion . They will be randomized according to a predetermined random order to vitamin regime or Centrum forte. Doses of risperidone will be lowered as clinically possible. Risperidone dose will be recorded weekly and will serve as a secondary outcome measure. A registered dietician will meet with each patient weekly and discourage refined sugar or excess fat and encourage regular fruit and vegetable consumption. High protein breakfast will be emphasized. Fifteen patients will be started yearly for three years.

The vitamin regimen will be as follows twice daily with food: