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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
Addis Ababa University
Amanuel Mental Hospital, Addis Ababa, Ethiopia
Information provided by (Responsible Party):
David C. Henderson, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01724476
First received: November 7, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Schizophrenia
Drug: folate with B12
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 240
Study Start Date: June 2014
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724476

Contacts
Contact: Teshome Shibre, MD shibreteshome@yahoo.com
Contact: Leah Briggs, BA lbriggs@partners.org

Locations
Ethiopia
Amanuel Mental Hospital Not yet recruiting
Addis Ababa, Ethiopia
Contact: Teshome Shibre, MD       shibreteshome@yahoo.com   
Principal Investigator: Teshome Shibre, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Addis Ababa University
Amanuel Mental Hospital, Addis Ababa, Ethiopia
Investigators
Principal Investigator: David C Henderson, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: David C. Henderson, Associate Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01724476     History of Changes
Other Study ID Numbers: 2011P002667, 2011D003142
Study First Received: November 7, 2012
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board
Ethiopia: Addis Ababa University, College of Health Sciences Institutional Review Board
Ethiopia: Ethical Review Committee
Ethiopia: Drug Administration and Control Authority

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Folic Acid
Vitamin B Complex
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014