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

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ClinicalTrials.gov Identifier: NCT01724476
Recruitment Status : Active, not recruiting
First Posted : November 9, 2012
Last Update Posted : August 31, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: folate with B12 Drug: placebo Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Trial of Folate With B12 in Patients With Schizophrenia With Residual Symptoms in Ethiopia
Actual Study Start Date : December 2014
Primary Completion Date : March 2017
Estimated Study Completion Date : December 2017

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Drug: folate with B12
Placebo Comparator: placebo
Subjects randomized to the placebo group will take 1 capsule of placebo per day.
Drug: placebo


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Change in psychotic symptoms as measured by the PANSS psychosis subscale score [ Time Frame: Baseline to Week 16 ]
    Examine the efficacy of folate supplementation with B12 for psychotic symptoms as measured by the PANSS psychosis subscale score

  2. Change in negative symptoms as measured by the Scale for Assessment of Negative Symptoms (SANS) [ Time Frame: Baseline to Week 16 ]
    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


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724476


Locations
Ethiopia
Amanuel Mental Hospital
Addis Ababa, Ethiopia
Sponsors and Collaborators
Massachusetts General Hospital
Addis Ababa University
Amanuel Mental Hospital, Addis Ababa, Ethiopia
Investigators
Principal Investigator: Gregory Fricchione, MD Massachusetts General Hospital
More Information

Responsible Party: Gregory Fricchione, Director, Chester M. Pierce, MD Division of Global Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01724476     History of Changes
Other Study ID Numbers: 2011P002667
2011D003142 ( Other Identifier: InfoEd proposal number )
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs