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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Capsule with folate, Vitamin B12 & pyridoxine
placebo
Sponsored by
Nathan Kline Institute for Psychiatric Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective Disorder, Homocysteine, Vitamins

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Nathan Kline Institute for Psychiatric Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

vitamin capsule

placebo capsule

Outcomes

Primary Outcome Measures

blood homocysteine levels

Secondary Outcome Measures

CGI (Clinical Global Improvement)
CDSS (Calgary Depression Scale for Schizophrenia)
WAIS-II Memory Scale (Immediate and Delayed)
WAIS Digit Symbol-Coding
Wisconsin Card Sorting Test
WAIS-II Letter-Number Sequencing Subtest

Full Information

First Posted
November 22, 2006
Last Updated
August 21, 2007
Sponsor
Nathan Kline Institute for Psychiatric Research
Collaborators
Stanley Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00403247
Brief Title
Effect of High-Dose B-Complex Vitamins on the Symptoms of Schizophrenia
Official Title
Double-Blind Vitamin Intervention to Lower Blood Homocysteine Levels: Amino Acid and Clinical Responses in Individuals With Schizophrenia.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nathan Kline Institute for Psychiatric Research
Collaborators
Stanley Medical Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Schizoaffective Disorder, Homocysteine, Vitamins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
vitamin capsule
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
placebo capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Capsule with folate, Vitamin B12 & pyridoxine
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo capsule
Primary Outcome Measure Information:
Title
blood homocysteine levels
Time Frame
12 weeks after baseline
Secondary Outcome Measure Information:
Title
CGI (Clinical Global Improvement)
Time Frame
12 weeks after baseline
Title
CDSS (Calgary Depression Scale for Schizophrenia)
Time Frame
12 weeks after baseline
Title
WAIS-II Memory Scale (Immediate and Delayed)
Time Frame
12 weeks after baseline
Title
WAIS Digit Symbol-Coding
Time Frame
12 weeks after baseline
Title
Wisconsin Card Sorting Test
Time Frame
12 weeks after baseline
Title
WAIS-II Letter-Number Sequencing Subtest
Time Frame
12 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William M Greenberg, M.D.
Organizational Affiliation
The Nathan Kline Institute for Psychiatric Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Nathan Kline Institute for Psychiatric Research
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States

12. IPD Sharing Statement

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

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