- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01724476
A Trial of Folate With B12 in Patients With Schizophrenia With Residual Symptoms in Ethiopia
August 14, 2018 updated by: Gregory Fricchione, Massachusetts General Hospital
A Placebo-Controlled Trial of Folate With B12 in Patients With Schizophrenia With Residual Symptoms in Ethiopia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Addis Ababa, Ethiopia
- Amanuel Mental Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: folate with B12
Subjects randomized to the folate with B12 group will take 1 capsule of 400mcg per day of folate with B12.
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Placebo Comparator: placebo
Subjects randomized to the placebo group will take 1 capsule of placebo per day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 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
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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
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Baseline to Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in psychotic symptoms as measured by the PANSS psychosis subscale score
Time Frame: Baseline to Week 16
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Examine the efficacy of folate supplementation with B12 for psychotic symptoms as measured by the PANSS psychosis subscale score
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Baseline to Week 16
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Change in negative symptoms as measured by the Scale for Assessment of Negative Symptoms (SANS)
Time Frame: Baseline to Week 16
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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
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Baseline to Week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gregory Fricchione, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2014
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
November 7, 2012
First Submitted That Met QC Criteria
November 8, 2012
First Posted (Estimate)
November 9, 2012
Study Record Updates
Last Update Posted (Actual)
August 15, 2018
Last Update Submitted That Met QC Criteria
August 14, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011P002667
- 2011D003142 (Other Identifier: InfoEd proposal number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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