Schizophrenia Clinical Trial
Official title:
A Placebo-Controlled Trial of Folate With B12 in Patients With Schizophrenia With Residual Symptoms in Ethiopia
Verified date | August 2018 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Amanuel Mental Hospital | Addis Ababa |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Addis Ababa University, Amanuel Mental Hospital, Addis Ababa, Ethiopia |
Ethiopia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | Baseline to Week 16 | |
Secondary | 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 | Baseline to Week 16 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |