Clinical trial NCT00403247: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Homocysteine
Vitamins
Lead sponsor: Nathan Kline Institute for Psychiatric Research
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2006-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: blood homocysteine levels
timeFrame: 12 weeks after baseline
Secondary outcomes:
measure: CGI (Clinical Global Improvement)
timeFrame: 12 weeks after baseline
measure: CDSS (Calgary Depression Scale for Schizophrenia)
timeFrame: 12 weeks after baseline
measure: WAIS-II Memory Scale (Immediate and Delayed)
timeFrame: 12 weeks after baseline
measure: WAIS Digit Symbol-Coding
timeFrame: 12 weeks after baseline
measure: Wisconsin Card Sorting Test
timeFrame: 12 weeks after baseline
measure: WAIS-II Letter-Number Sequencing Subtest
timeFrame: 12 weeks after baseline
Other outcomes:
Locations:
city: Orangeburg
country: United States
facility: The Nathan Kline Institute for Psychiatric Research
state: New York
Study officials:
affiliation: The Nathan Kline Institute for Psychiatric Research
name: William M Greenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: