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

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ClinicalTrials.gov Identifier: NCT00403247
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : August 23, 2007
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Nathan Kline Institute for Psychiatric Research

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine Other: placebo Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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.
Study Start Date : July 2004
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
vitamin capsule
 Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine
Placebo Comparator: B
placebo capsule
 Other: placebo
placebo capsule


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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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
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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
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Principal Investigator: William M Greenberg, M.D. The Nathan Kline Institute for Psychiatric Research
More Information
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ClinicalTrials.gov Identifier: NCT00403247    
Other Study ID Numbers: 04T-536
First Posted: November 23, 2006    Key Record Dates
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:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Vitamin B 12
Hydroxocobalamin
 Pyridoxine
Vitamins
Micronutrients
Physiological Effects of Drugs
Vitamin B Complex
Hematinics