Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Schizophrenia, Schizoaffective Disorder, Homocysteine, Vitamins
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.
Interventions
DIETARY_SUPPLEMENTCapsule with folate, Vitamin B12 & pyridoxine
OTHERplacebo
placebo capsule
Sponsors
Stanley Medical Research Institute
Nathan Kline Institute for Psychiatric Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood homocysteine levels | 12 weeks after baseline |
Secondary
| Measure | Time frame |
|---|---|
| CDSS (Calgary Depression Scale for Schizophrenia) | 12 weeks after baseline |
| WAIS-II Memory Scale (Immediate and Delayed) | 12 weeks after baseline |
| CGI (Clinical Global Improvement) | 12 weeks after baseline |
| Wisconsin Card Sorting Test | 12 weeks after baseline |
| WAIS-II Letter-Number Sequencing Subtest | 12 weeks after baseline |
| WAIS Digit Symbol-Coding | 12 weeks after baseline |
Countries
United States
Outcome results
None listed