l-threonic acid magnesium salt (l-tams) in adhd

Conditions: Attention Deficit/Hyperactivity Disorder; ADHD

Summary: this study is a 12-week, open-label pilot study to test the effects of mmfs-201-301 on cognition and function in adults with adhd. subjects may enter the trial on a stable dose of medication for adhd, and mmfs-201-301 will be given. subjects who do not enter on a stable dose of adhd medication will receive mmfs-201-301 alone.


Eligibility criteria:
inclusion criteria: * male or female adults ages 18-55 years of age * a diagnosis of childhood-onset attention deficit/hyperactivity disorder (adhd), meeting the diagnostic and statistical manual, fifth edition (dsm-v) criteria for adhd in adulthood, including at least 5 current symptoms of inattentive or impulsive-hyperactive traits, and childhood onset by age 12, defined as two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12 * a score of 20 or more on the adult adhd investigator symptom report scale (aisrs), and, for those individuals stably treated with stimulants, a clinical global impression -adhd (cgi-adhd) severity score of no greater than 4 ("moderately ill") * subjects on a stable dose of stimulant medication must be treated on the same dose for at least 1 month prior to study entry exclusion criteria: * a history of intolerance to magnesium supplementation, or the ingredients in mmfs202 (6-hour release) and mmfs302 (12-hour release) * pregnant or nursing females * a known unstable medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including hypertension ≥ 140/90 mmhg at screening), endocrinologic (e.g. thyroid), neurologic (e.g. seizure), immunologic, hematologic, or psychiatric (other than adhd) disorder); individuals with kidney dysfunction will be excluded, as dysfunctional kidneys may have difficulty clearing the magnesium from the body (which can result in dangerously high magnesium levels); individuals with heart block will be excluded from the study * any medical condition that the principal investigator (pi) believes will be exacerbated by study participation * a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening * a known history of narrow-angle glaucoma * current (within 3 months) dsm-v criteria for abuse or dependence with any psychoactive substance other than nicotine * intelligence quotient (iq) less than 80 (based on the wechsler abbreviated scale of intelligence-ii full scale iq calculation) * multiple adverse drug reactions * any other concomitant medication with primarily central nervous system activity as specified in the study protocol * current use of a monoamine-oxidase inhibitor (maoi) or use within the past two weeks * current use of antibiotics, as the study agent may reduce the absorption of antibiotics * subjects may not take any of the following substances for at least 7 days prior to baseline and throughout the study: calcium channel blockers; any psychoactive medications; any medications known to interact with magnesium; supplemental magnesium or any magnesium-containing products; all dietary or herbal supplements or products including those purported to improve memory, improve sleep, or decrease stress. * investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild

Keywords: attention deficit/hyperactivity disorder adhd attention deficit disorder add magnesium