We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00403247
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00403247
First Posted: November 23, 2006
Last Update Posted: August 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stanley Medical Research Institute
Information provided by:
Nathan Kline Institute for Psychiatric Research
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00403247     History of Changes
Other Study ID Numbers: 04T-536
First Submitted: November 22, 2006
First Posted: November 23, 2006
Last Update Posted: August 23, 2007
Last Verified: August 2007

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

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Vitamins
Vitamin B 12
Hydroxocobalamin
Pyridoxine
Micronutrients
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex
Hematinics