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

NCT ID: NCT00403247

Last Updated: 2007-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

vitamin capsule

Group Type EXPERIMENTAL

Capsule with folate, Vitamin B12 & pyridoxine

Intervention Type DIETARY_SUPPLEMENT

B

placebo capsule

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo capsule

Interventions

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Capsule with folate, Vitamin B12 & pyridoxine

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo capsule

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanley Medical Research Institute

OTHER

Sponsor Role collaborator

Nathan Kline Institute for Psychiatric Research

OTHER

Sponsor Role lead

Principal Investigators

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William M Greenberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Nathan Kline Institute for Psychiatric Research

Locations

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The Nathan Kline Institute for Psychiatric Research

Orangeburg, New York, United States

Site Status

Countries

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United States

Other Identifiers

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04T-536

Identifier Type: -

Identifier Source: org_study_id