Back to resultsA Trial of Folate With B12 in Patients With Schizophrenia With Residual Symptoms in Ethiopia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Ethiopia
Study Type
Interventional
Intervention
folate with B12
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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)
- Unstable psychiatric illness
- Seizure disorder
- Pregnancy or nursing
Sites / Locations
- Amanuel Mental Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
folate with B12
placebo
Arm Description
Subjects randomized to the folate with B12 group will take 1 capsule of 400mcg per day of folate with B12.
Subjects randomized to the placebo group will take 1 capsule of placebo per day.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in psychotic symptoms as measured by the PANSS psychosis subscale score
Examine the efficacy of folate supplementation with B12 for psychotic symptoms as measured by the PANSS psychosis subscale score
Change in negative symptoms as measured by the Scale for Assessment of Negative Symptoms (SANS)
Examine the efficacy of folate supplementation with B12 for negative symptoms as measured by the modified Scale for Assessment of Negative Symptoms (SANS) total score
Full Information
NCT ID
NCT01724476
First Posted
November 7, 2012
Last Updated
August 14, 2018
Sponsor
Massachusetts General Hospital
Collaborators
Addis Ababa University, Amanuel Mental Hospital, Addis Ababa, Ethiopia
1. Study Identification
Unique Protocol Identification Number
NCT01724476
Brief Title
A Trial of Folate With B12 in Patients With Schizophrenia With Residual Symptoms in Ethiopia
Official Title
A Placebo-Controlled Trial of Folate With B12 in Patients With Schizophrenia With Residual Symptoms in Ethiopia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Addis Ababa University, Amanuel Mental Hospital, Addis Ababa, Ethiopia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This is a 16-week, randomized, double-blind, placebo-controlled study of Folate 2mg plus B12 400mcg, as an adjunctive therapy in approximately 240 consecutive outpatients with schizophrenia from Amanuel Hospital, which is based at Addis Ababa, Ethiopia will be enrolled and screened for eligibility. The goal is to randomize and complete 200 subjects from the 240 enrolled. A Sequential Parallel Design for Double-Blind Phase will be utilized. During the first phase of double-blind adjunctive treatment, eligible patients (n=200) are randomized to adjunctive treatment with either folate and vitamin B12 (n=60) or placebo (n=150), with a 2:3:3 ratio for random assignment to the treatment sequences drug/drug (DD; n=70), placebo/placebo (PP; n=70), and placebo/drug (PD; n=75), while all continue to receive their antipsychotic agent for the entire duration of the study. Assuming a 10% drop-out rate during the first phase, 126 patients on placebo will complete the first 56-day phase, and 54 patients on folate and vitamin B12 will complete the first 56-day phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
folate with B12
Arm Type
Active Comparator
Arm Description
Subjects randomized to the folate with B12 group will take 1 capsule of 400mcg per day of folate with B12.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to the placebo group will take 1 capsule of placebo per day.
Intervention Type
Drug
Intervention Name(s)
folate with B12
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change in symptoms of schizophrenia as measured by the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Description
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
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Change in psychotic symptoms as measured by the PANSS psychosis subscale score
Description
Examine the efficacy of folate supplementation with B12 for psychotic symptoms as measured by the PANSS psychosis subscale score
Time Frame
Baseline to Week 16
Title
Change in negative symptoms as measured by the Scale for Assessment of Negative Symptoms (SANS)
Description
Examine the efficacy of folate supplementation with B12 for negative symptoms as measured by the modified Scale for Assessment of Negative Symptoms (SANS) total score
Time Frame
Baseline to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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)
Unstable psychiatric illness
Seizure disorder
Pregnancy or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Fricchione, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amanuel Mental Hospital
City
Addis Ababa
Country
Ethiopia
12. IPD Sharing Statement
Learn more about this trial
A Trial of Folate With B12 in Patients With Schizophrenia With Residual Symptoms in Ethiopia
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