Effect of High-Dose B-Complex Vitamins on the Symptoms of Schizophrenia

August 21, 2007 updated by: Nathan Kline Institute for Psychiatric Research

Double-Blind Vitamin Intervention to Lower Blood Homocysteine Levels: Amino Acid and Clinical Responses in Individuals With Schizophrenia.

The purpose of this study is to determine whether individuals with schizophrenia who will take a high dose of the B-vitamins folate, B12 and pyridoxine, may experience improvement in their symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Individuals with schizophrenia often experience disturbing residual symptoms, even with the best available current treatments. Homocysteine, normally found in the body, can interfere with NMDA-glutamate receptor function, and this might be responsible for some of the symptoms of schizophrenia. This double-blind protocol will have study participants who suffer from schizophrenia take either a high-dose combination of folate, B12 and pyridoxine (a combination that can lower homocysteine in the body) or placebo for three months. Clinical measures (e.g., PANSS, CGI) will be taken to determine whether those taking the vitamin combination experience clinical benefit.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Orangeburg, New York, United States, 10962
        • The Nathan Kline Institute for Psychiatric Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Schizophrenia or Schizoaffective Disorder
  • Ages 18-65, male or female
  • Treatment regimen includes a new-generation antipsychotic (clozapine, olanzapine,risperidone, quetiapine, ziprasidone or aripiprazole)
  • Stable medication for 4 weeks prior to screening visit

Exclusion Criteria:

  • Diagnosis of active substance use disorder within the last month
  • Already taking vitamin supplements totaling > 400 mcg folic acid per day, or regular B12 injections
  • Pregnant or breastfeeding
  • Seizure disorder
  • Non-English speaking
  • Without capacity to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
vitamin capsule
Dietary supplement: Capsule with folate, Vitamin B12 & pyridoxine
Placebo Comparator: B
placebo capsule
Other: placebo
placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood homocysteine levels
Time Frame: 12 weeks after baseline
12 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
CGI (Clinical Global Improvement)
Time Frame: 12 weeks after baseline
12 weeks after baseline
CDSS (Calgary Depression Scale for Schizophrenia)
Time Frame: 12 weeks after baseline
12 weeks after baseline
WAIS-II Memory Scale (Immediate and Delayed)
Time Frame: 12 weeks after baseline
12 weeks after baseline
WAIS Digit Symbol-Coding
Time Frame: 12 weeks after baseline
12 weeks after baseline
Wisconsin Card Sorting Test
Time Frame: 12 weeks after baseline
12 weeks after baseline
WAIS-II Letter-Number Sequencing Subtest
Time Frame: 12 weeks after baseline
12 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nathan Kline Institute for Psychiatric Research

Collaborators

Stanley Medical Research Institute

Investigators

  • Principal Investigator: William M Greenberg, M.D., The Nathan Kline Institute for Psychiatric Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

November 22, 2006

First Submitted That Met QC Criteria

November 22, 2006

First Posted (Estimate)

November 23, 2006

Study Record Updates

Last Update Posted (Estimate)

August 23, 2007

Last Update Submitted That Met QC Criteria

August 21, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04T-536

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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