A Placebo-controlled Trial of Folate with B12 in Patients with Schizophrenia with Residual Symptoms in Ethiopia Using a Sequential Parallel Comparison Design.
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Date
2014-08-11
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Abstract
Background: Approximately 30% of patients with schizophrenia suffer from treatmentresistant
psychotic symptoms, which can produce substantial distress, result in hospitalization and disrupt school or work functioning. Studies have found low blood
folate concentrations in psychiatric populations and recent reports have consistently
linked schizophrenia to low folate levels. We aim to examine the efficacy of a four-month
trial of folate with B12 supplementation for reducing symptoms of schizophrenia.
Methods: This study is a randomized, sequential parallel comparison design (SPCD) for
double-blind phase fixed dose, 4-month trial of folate plus B12 as add-on therapy to
reduce symptoms of schizophrenia. Participants will be adults (ages 18 to 65 years)
diagnosed with schizophrenia, any subtype, who are psychiatrically and medically stable,
but have residual positive or negative symptoms of moderate or greater intensity, despite
antipsychotic treatment. The study is divided into 2 double-blind phases of 56 days each.
Two hundred total participants will be randomized to adjunctive treatment with either
folate with vitamin B12 (n=50) or placebo (n=150), with a 2:3:3 ratio for random
assignment to the treatment sequences drug/drug (DD; n=50), placebo/placebo (PP;
n=75), and placebo/drug (PD; n=75), while all continue to receive their current
antipsychotic agent for the duration of the study. Diagnosis will be established using the
Structured Clinical Interview for DSM-IV for clinical trials (SCID-CT). The primary
outcome measure will be change in symptom severity measured by the change from
baseline in Positive and Negative Syndrome Scale (PANSS) total score. Secondary
outcome measures will include change in severity of psychotic symptoms as measured
by the PANSS psychosis subscale score; and change in severity of negative symptoms
as measured by the modified Scale for Assessment of Negative Symptoms (SANS) total
score. Key assessments for primary and secondary outcomes will be conducted at
baseline, week 8, and week 16.
Trial Registration: Clinicaltrials.gov identifier: NCT01724476.
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Keywords
Folate, vitamin B12, schizophrenia, negative symptoms, sequential parallel comparison design, Ethiopia
Citation
Borba Christina P C, Fekadu Abebaw, Teferra Solomon, Bekele Desalegn, Shibre Teshome, Oppenheim Claire E, Biressaw Silenat, Mulugeta Anwar, Schoenfeld David A, Henderson David C. A Placebo-controlled Trial of Folate with B12 in Patients with Schizophrenia with Residual Symptoms in Ethiopia Using a Sequential Parallel Comparison Design. British Journal of Medicine and Medical Research. 2014 Aug; 4(23): 4090-4104.