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

NCT01724476 | Completed Phase 4 DMC

• 2 other identifiers: 2011P0026672011D003142
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change in symptoms of schizophrenia as measured by the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

  Examine the efficacy of a four-month trial of folate supplementation with B12 for potentially reducing symptoms of schizophrenia as measured by the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

  Baseline to Week 16

Secondary Outcomes (2)

• Change in psychotic symptoms as measured by the PANSS psychosis subscale score

  Baseline to Week 16

• Change in negative symptoms as measured by the Scale for Assessment of Negative Symptoms (SANS)

  Baseline to Week 16

Study Arms (2)

folate with B12

ACTIVE COMPARATOR

Subjects randomized to the folate with B12 group will take 1 capsule of 400mcg per day of folate with B12.

Drug: folate with B12

placebo

PLACEBO COMPARATOR

Subjects randomized to the placebo group will take 1 capsule of placebo per day.

Drug: placebo

Interventions

folate with B12 DRUG

folate with B12

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia, any subtype
• Male or female
• Age 18-65 years
• Treated with an antipsychotic for at least 6 months at a stable dose for at least 6 weeks
• PANSS total score of at least 60, with at least a 3 (moderate) on one negative symptom item or on one positive symptom item.
• No acute medical problems; any chronic medical condition (e.g. hypertension) consistently treated and stable during the 1 month prior to participation

You may not qualify if:

• Unable to provide informed consent
• Serum B12 concentration less than 300mcg/L; Complete Blood Count (CBC) results consistent with megaloblastic anemia
• Serum creatinine concentration greater than 1.4
• Current use of folate or B12 supplementation
• Current use of any of the following medications: phenobarbital, phenytoin, carbamazepine, valproic acid, fosphenytoin, primidone or pyrimethamine; antimalarial drugs
• Alcohol or other substance abuse within 3 months (nicotine allowed)
• Unstable psychiatric illness
• Seizure disorder
• Pregnancy or nursing

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Addis Ababa University: collaborator
• Amanuel Mental Hospital, Addis Ababa, Ethiopia: collaborator

Study Sites (1)

Amanuel Mental Hospital

Addis Ababa, Ethiopia

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Folic Acid; Vitamin B 12

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Gregory Fricchione, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Chester M. Pierce, MD Division of Global Psychiatry

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 9, 2012
• Study Start: December 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

ET (1)