Folate Supplementation in Schizophrenia

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: Folate

Study type: Interventional

Funder types: Other

Identifiers

NCT00249288

2004P-000495

Details and patient eligibility

About

This study aims to examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low folate is associated with negative symptoms, and to examine the efficacy of folate supplementation for reducing negative symptoms.

Full description

This study is a three-month, placebo-controlled trial of folate 2mg/d in 50 schizophrenia patients who score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale. The specific aims of this study are:

• To examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between patients at baseline, including dietary intake and cigarette smoking.
• To test the hypothesis that low folate is associated with negative symptoms by examining correlations between red blood cell folate concentrations and clinical ratings of negative symptoms and by comparing folate concentrations in deficit syndrome versus non-deficit syndrome patients. We will also control for dietary intake cigarettes smoking, gender, and age.
• To examine the efficacy of folate supplementation for reducing negative symptoms

Enrollment: 46 patients

Sex: All

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Schizophrenia, any subtype
2. Ages 18-68
3. Male or female
4. A score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale
5. Stable antipsychotic dose for > 6 weeks
6. Capable of providing informed consent

Exclusion criteria

1. Unstable medical illness
2. Substance abuse
3. Megaloblastic anemia
4. Non-english speaking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

Folate

Experimental group

Description:

Participants will receive a 2 mg/ day dose of folate, for 12 weeks

Treatment:

Drug: Folate

Placebo

Placebo Comparator group

Description:

Participants will receive a 2 mg/ day dose of placebo, for 12 weeks

Treatment:

Drug: Placebo