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

NCT01724476 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-08-15

No results posted yet for this study

Summary

The investigators propose to conduct a randomized Sequential Parallel Design for Double-Blind Phase fixed dose, 4-month trial of folate plus B12 as add-on therapy in 200 Ethiopian subjects with schizophrenia with stable residual positive or negative symptoms.

Conditions

Interventions

DRUG

folate with B12

DRUG

placebo

Sponsors & Collaborators

  • Addis Ababa University

    collaborator OTHER
  • Amanuel Mental Hospital, Addis Ababa, Ethiopia

    collaborator UNKNOWN
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Gregory Fricchione, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-03-31
Completion
2017-12-31

Countries

  • Ethiopia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01724476 on ClinicalTrials.gov