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

Sponsors and Collaborators:	Nathan Kline Institute for Psychiatric Research Stanley Medical Research Institute
Information provided by:	Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:	NCT00403247

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

MedlinePlus related topics: Schizophrenia

Drug Information available for: Folic acid Vitamin B 12 Hydroxocobalamin Vitamin B 6 5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride Pyridoxine Homocysteine Amino acids, branched-chain

U.S. FDA Resources

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

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
A: Experimental vitamin capsule	Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine
B: Placebo Comparator 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

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

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

Keywords provided by Nathan Kline Institute for Psychiatric Research:

Schizophrenia
Schizoaffective Disorder
Homocysteine
Vitamins

Study placed in the following topic categories:

Folic Acid
Schizophrenia
Mental Disorders
Hydroxocobalamin
Vitamin B 12

Pyridoxine
Psychotic Disorders
Vitamin B 6
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Vitamin B Complex
Growth Substances
Vitamins

Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009