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

Nathan Kline Institute for Psychiatric Research

Status

Completed

Conditions

Schizophrenia

Schizoaffective Disorder

Treatments

Other: placebo

Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine

Study type

Interventional

Funder types

Other

Identifiers

NCT00403247

04T-536

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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