NCT00140166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

First QC Date

August 31, 2005

Last Update Submit

November 23, 2009

Conditions

Acute Schizophrenia

Keywords

schizophrenianiacinamide

Outcome Measures

Primary Outcomes (2)

  • Brief Psychiatric Rating Scale

  • Global Clinical Assessment

Interventions

niacinamideDRUG
pyridoxineDRUG
ascorbateDRUG

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beersheva Mental Health Center

Beersheva, Israel

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

NiacinamidePyridoxine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingVitamin B 6Picolines

Study Officials

  • Vladimir Lerner, MD

    Beersheva Mental Health Center

    PRINCIPAL INVESTIGATOR

  • RH Belmaker, MD

    Ben-Gurion University of the Negev

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 1, 2005

Study Start

July 1, 2005

Study Completion

May 1, 2008

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

IL(1)