Folate Supplementation in Schizophrenia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of Vitamin Supplementation in Treating People With Residual Symptoms of Schizophrenia

NCT00611806

Schizophrenia

COMPLETED PHASE4

A Placebo-Controlled Study of Physiologic Effects of L-methylfolate in Schizophrenia Patients

NCT01091506

Schizophrenia

COMPLETED NA

A Trial of Folate With B12 in Patients With Schizophrenia With Residual Symptoms in Ethiopia

NCT01724476

Schizophrenia

COMPLETED PHASE4

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

NCT00403247

Schizophrenia Schizoaffective Disorder

COMPLETED NA

Evaluation of Mirtazapine and Folic Acid for Schizophrenia:

NCT01263080

Schizophrenia

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Folate

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

Group Type EXPERIMENTAL

Folate

Intervention Type DRUG

Folic acid taken as 2, 1mg capsule daily for 12 weeks

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo taken as 2, 1mg capsule daily for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Folate

Folic acid taken as 2, 1mg capsule daily for 12 weeks

Intervention Type DRUG

Placebo

Placebo taken as 2, 1mg capsule daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Folate or folic acid

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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