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Completed

NCT Number: NCT00403247

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

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Nathan Kline Institute for Psychiatric Research

Orangeburg, New York, 10962, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capsule with folate, Vitamin B12 & pyridoxine

Dietary Supplement

Placebo

Other

placebo capsule

Primary outcomes

  1. blood homocysteine levels

    Time frame: 12 weeks after baseline

Secondary outcomes

  1. CGI (Clinical Global Improvement)

    Time frame: 12 weeks after baseline

  2. CDSS (Calgary Depression Scale for Schizophrenia)

    Time frame: 12 weeks after baseline

  3. WAIS-II Memory Scale (Immediate and Delayed)

    Time frame: 12 weeks after baseline

  4. WAIS Digit Symbol-Coding

    Time frame: 12 weeks after baseline

  5. Wisconsin Card Sorting Test

    Time frame: 12 weeks after baseline

  6. WAIS-II Letter-Number Sequencing Subtest

    Time frame: 12 weeks after baseline

Sponsors and collaborators

Lead sponsor

Nathan Kline Institute for Psychiatric Research

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2007
First posted
Nov 23, 2006
Registry last updated
Aug 23, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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