10 completed, 2 unknown, 1 terminated. 4 Not applicable, 1 Phase 2, 1 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 4 | Completed 3, Unknown 1 |
| Phase 2 | 1 | Completed 1 |
| Phase 3 | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| The Use Of L-Methylfolate As A Treatment For Depression L-methylfolate - Depression | Not applicable | Completed | University of Florida | 57 | 2016-02-01 | 2023-06-07 |
| L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults L-methylfolate, OROS-Methylphenidate, Placebo - Attention Deficit Hyperactivity Disorder | Phase 2 / Phase 3 | Completed | Massachusetts General Hospital | 47 | 2014-05-01 | 2017-11-14 |
| The Nutritional Benefits of Metanx in Patients With Diabetic Peripheral Neuropathy (MEDIAN) Metanx, Placebo - Diabetic Peripheral Neuropathy, B Vitamin Deficiency | Not applicable | Unknown | Pamlab, Inc. | 238 | 2013-11-01 | 2016-01-18 |
| A Retrospective Analysis of Cerefolin NAC® in Cognitively Impaired Patients Mild Cognitive Impairment | Unknown | Pamlab, Inc. | 700 | 2013-01-01 | 2014-03-24 | |
| Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements Mild Cognitive Impairment, Alzheimer's Disease | Completed | Pamlab, Inc. | 121 | 2012-12-01 | 2015-04-28 | |
| NAC-003 P.L.U.S. Program (Progress Through Learning Understanding & Support) CerefolinNAC® - Early Memory Loss, Mild Cognitive Impairment | Completed | Pamlab, Inc. | 204 | 2011-05-01 | 2013-05-09 | |
| Néevo®/NéevoDHA® P.L.U.S. Program (Progress Through Learning, Understand & Support) Néevo®/ NéevoDHA® - Pregnancy | Terminated | Pamlab, Inc. | 53 | 2011-01-01 | 2013-05-01 | |
| Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support) Deplin® - Major Depressive Disorder | Completed | Pamlab, Inc. | 554 | 2010-11-01 | 2014-06-03 | |
| A Placebo-Controlled Study of Physiologic Effects of L-methylfolate in Schizophrenia Patients Placebo, L-methylfolate - Schizophrenia | Not applicable | Completed | Pamlab, Inc. | 55 | 2010-03-01 | 2016-08-03 |
| A Retrospective Analysis of Neevo®/Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy Neevo® (a medical food), Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12) - Anemia in Pregnancy, Preeclampsia | Completed | Pamlab, Inc. | 100 | 2009-12-01 | 2013-04-16 | |
| Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis L-methylfolate, Selective serotonin reuptake inhibitor (SSRI), Serotonin and norepinephrine reuptake inhibitor (SNRI) - Major Depressive Disorder | Completed | Pamlab, Inc. | 242 | 2009-08-01 | 2013-12-19 | |
| Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN) Metanx (a medical food), Metanx placebo - Type 2 Diabetic Peripheral Neuropathy (DPN) | Phase 4 | Completed | Pamlab, Inc. | 214 | 2008-06-01 | 2013-08-30 |
| Study of the Effects of Cerefolin NAC on Inflammation Blood Markers in Older Individuals With Memory Complaints Cerefolin NAC (a medical food), Cerefolin NAC placebo - Subjective Memory Loss in Older Persons | Not applicable | Completed | Rush University Medical Center | 104 | 2007-11-01 | 2013-05-23 |
Depression (5) · Cognitive Dysfunction (3) · Alzheimer Disease (2) · Dementia (2) · Depressive Disorder, Major (2) · Iron Deficiencies (2) · Memory Disorders (2) · Attention Deficit Disorder with Hyperactivity (1) · Dementia, Vascular (1) · Diabetes Mellitus (1) · Homocysteinemia (1) · Hyperhomocysteinemia (1) · Pre-Eclampsia (1) · Schizophrenia (1) · Vitamin B Deficiency (1)
5-methyltetrahydrofolate (5) · metanx (2) · Folic Acid (1) · Iron (1) · Methylphenidate (1) · Prenatal Care (1) · Selective Serotonin Reuptake Inhibitors (1) · Serotonin and Noradrenaline Reuptake Inhibitors (1) · Vitamin B 12 (1)
United States (13)
Craig Surman, MD (1) · Donald E Schmechel, M.D. (1) · Emily Clionsky, MD (1) · Gary Kanter, M.D. (1) · Joshua Roffman, MD (1) · Lawrence D Ginsberg, MD (1) · Noe Lira, M.D. (1) · Raj C Shah, MD (1) · Richard C Shelton, M.D. (1) · Roy Freeman, MD (1) · Sloan Manning, M.D. (1) · Susan Bentley, CRNP (1) · Vivian Fonseca, MD (1) · William R Shankle, MS, MD, FACP (1)