The Cambridge (Massachusetts) Health Alliance’s Psychopharmacology Research Program is recruiting patients with depression for a Phase IV study to “determine the clinical response rate” for a treatment regimen of the three nutritional supplements L-methionine, betaine, and folate for unipolar depression. The Alliance is a Harvard Medical School teaching affiliate.
Subjects may be ages 18 through 64, either male or female. The study will be 6 weeks long and will include 9 clinical visits, therefore requiring that subjects be located within traveling distance of Cambridge. It is an open label, non-randomized, uncontrolled study, meaning all patients will take the supplements and no patients will take a placebo (fake dose). And it will measure the treatment’s safety and effectiveness.
Official Title: “Phase 4 Study: An Open Study of the Efficacy and Tolerability in Unipolar Depression of Augmentation of the One-Carbon Cycle With L-Methionine, Betaine and Folate” - ClinicalTrials.gov number NCT00226356 [Note: The 'one-carbon cycle' is a metabolic pathway associated with metabolism of neurotransmitters.]
Critera for Inclusion:
n DSM-IV diagnosis of MDD (major depressive disorder) or DDNOS (dissociative disorder not otherwise specified);
n Clinical indication for treatment of current depressive symptoms;
n HDS (Hospital Anxiety and Depression Scale) > 18;
n Women of reproductive potential must use an acceptable method of birth control.
n Treatment with another psychotropic drug;
n History of mania or hypomania;
n History of bipolar illness in first-degree relatives;
n Active homicidality;
n Pregnant; trying to become pregnant, or nursing;
n Unstable medical condition;
n Current substance abuse in the past month;
n History of sulfa allergy
Please refer to this study by ClinicalTrials.gov identifier number NCT00226356
Cambridge Health Alliance, Cambridge, Massachusetts
Vanessa Stan, AB Phone: 617-591-6116 E-mail: firstname.lastname@example.org
Principal Investigator: Robert T Dunn, MD, PhD
Co-sponsor: National Alliance for Research on Schizophrenia and Depression.
Health Authority: U.S. Institutional Review Board