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

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT00403247
First received: November 22, 2006
Last updated: August 21, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind Vitamin Intervention to Lower Blood Homocysteine Levels: Amino Acid and Clinical Responses in Individuals With Schizophrenia.

Resource links provided by NLM:


Further study details as provided by Nathan Kline Institute for Psychiatric Research:

Primary Outcome Measures:
  • blood homocysteine levels [ Time Frame: 12 weeks after baseline ]

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

Enrollment: 50
Study Start Date: July 2004
Study Completion Date: July 2007
Arms Assigned Interventions
Experimental: A
vitamin capsule
Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine
Placebo Comparator: B
placebo capsule
Other: placebo
placebo capsule

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403247

Locations
United States, New York
The Nathan Kline Institute for Psychiatric Research
Orangeburg, New York, United States, 10962
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Stanley Medical Research Institute
Investigators
Principal Investigator: William M Greenberg, M.D. The Nathan Kline Institute for Psychiatric Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00403247     History of Changes
Other Study ID Numbers: 04T-536
Study First Received: November 22, 2006
Last Updated: August 21, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Nathan Kline Institute for Psychiatric Research:
Schizophrenia
Schizoaffective Disorder
Homocysteine
Vitamins

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Vitamin B 12
Vitamins
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex

ClinicalTrials.gov processed this record on November 25, 2014