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

Sponsor:	Nathan Kline Institute for Psychiatric Research
Collaborator:	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

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:

MedlinePlus related topics: B Vitamins Schizophrenia

Drug Information available for: Pyridoxine hydrochloride Pyridoxine Vitamin B 12 Hydroxocobalamin Homocysteine Vitamin B 6

U.S. FDA Resources

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

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
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Vitamin B 12
Hydroxocobalamin
Pyridoxine
Vitamin B Complex

Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012