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

Schizophrenia Clinical Trial

Official title:

Double-Blind Vitamin Intervention to Lower Blood Homocysteine Levels: Amino Acid and Clinical Responses in Individuals With Schizophrenia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403247
• Other study ID #: 04T-536
• Status: Completed
• Phase: N/A
• First received: November 22, 2006
• Last updated: August 21, 2007
• Start date: July 2004
• Est. completion date: July 2007

Study information

• Verified date: August 2007
• Source: Nathan Kline Institute for Psychiatric Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Dietary Supplement:
• Capsule with folate, Vitamin B12 & pyridoxine

Other:
• placebo
placebo capsule

Locations

Country	Name	City	State
United States	The Nathan Kline Institute for Psychiatric Research	Orangeburg	New York

Sponsors (2)

Lead Sponsor	Collaborator
Nathan Kline Institute for Psychiatric Research	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood homocysteine levels		12 weeks after baseline
Secondary	CGI (Clinical Global Improvement)		12 weeks after baseline
Secondary	CDSS (Calgary Depression Scale for Schizophrenia)		12 weeks after baseline
Secondary	WAIS-II Memory Scale (Immediate and Delayed)		12 weeks after baseline
Secondary	WAIS Digit Symbol-Coding		12 weeks after baseline
Secondary	Wisconsin Card Sorting Test		12 weeks after baseline
Secondary	WAIS-II Letter-Number Sequencing Subtest		12 weeks after baseline