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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Addis Ababa University; Amanuel Mental Hospital, Addis Ababa, Ethiopia
• Treatments: Folic Acid; Vitamin B Complex

Criteria

Inclusion Criteria:

1. Diagnosis of schizophrenia, any subtype

2. Male or female

3. Age 18-65 years

4. Treated with an antipsychotic for at least 6 months at a stable dose for at least 6 weeks

5. PANSS total score of at least 60, with at least a 3 (moderate) on one negative symptom item or on one positive symptom item.

6. No acute medical problems; any chronic medical condition (e.g. hypertension) consistently treated and stable during the 1 month prior to participation

Exclusion Criteria:

1. Unable to provide informed consent

2. Serum B12 concentration less than 300mcg/L; Complete Blood Count (CBC) results consistent with megaloblastic anemia

3. Serum creatinine concentration greater than 1.4

4. Current use of folate or B12 supplementation

5. Current use of any of the following medications: phenobarbital, phenytoin, carbamazepine, valproic acid, fosphenytoin, primidone or pyrimethamine; antimalarial drugs

6. Alcohol or other substance abuse within 3 months (nicotine allowed)

7. Subjects with a history of clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorders (e.g. unstable angina, decompensated congestive heart failure, Central Nervous System (CNS) infection or history of HIV seropositivity), which would pose a risk to the patient if they were to participate in the study or that might confound the results of the study. Active medical conditions that are minor or well controlled are not exclusionary if they do not affect risk to the patient or the study results. For example, the following are not exclusionary: a) stable and well- controlled hypertension; b) asthma (no serious attacks in the past year)

8. Unstable psychiatric illness

9. Seizure disorder

10. Pregnancy or nursing