L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults
This pilot study seeks to evaluate initial evidence for efficacy and tolerability of L-methylfolate supplementation to OROS-Methylphenidate pharmacotherapy in treating Attention Deficit Hyperactivity Disorder (ADHD) and associated symptoms in adults with ADHD. The investigators will conduct a 12-week double-blind randomized placebo-controlled trial with L-methylfolate supplementing open-label OROS-Methylphenidate (OROS-MPH) treatment. The investigators propose to examine 40 adult (ages 18-55) subjects satisfying the DSM-IV diagnostic criteria for ADHD.
Study Start Date
Estimated Completion Date
- Drug: OROS-Methylphenidate
- Drug: Placebo
- Drug: L-methylfolate
- Psychiatry: Neuro/Psych Pharmacol,Other Psychiatry
- Pharmacy: Drug Trials,Neuro/Psych pharmacology
- Attention Deficit Disorder with Hyperactivity
Massachusetts General Hospital -- 2012-P-000379
Phase 2/Phase 3
Massachusetts General Hospital
1. Male or female adults ages 18-55 years of age.
2. A diagnosis of childhood onset ADHD, meeting all but the age of onset criteria
according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition [American Psychiatric Association, 2000 #23616] (DSM-IV), based on clinical
assessment. Childhood onset will be defined according to established research
criteria, requiring onset of two symptoms of inattentive or of impulsive/hyperactive
traits by the age of 12.
3. A score of 24 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS).
1. A history of non-response or intolerance to methylphenidate at adequate doses as
determined by the clinician.
2. A history of intolerance to L-methylfolate supplementation.
3. Pregnant or nursing females.
4. Serious, unstable medical illness including hepatic, renal, gastroenterological,
respiratory, cardiovascular, endocrinologic (thyroid), neurologic (seizure),
immunologic, or hematologic disease.
6. Clinically unstable psychiatric conditions including suicidality, homicidality,
bipolar disorder, psychosis, or lifetime history of a clinically serious condition
potentially exacerbated by a stimulant such as mania, or psychosis.
7. Tics or a family history or diagnosis of Tourette's syndrome.
8. Current (within 3 months) DSM-IV criteria for abuse or dependence with any
psychoactive substance other than nicotine.
9. Multiple adverse drug reactions.
10. Any other concomitant medication with primarily central nervous system activity other
than specified in Concomitant Medication portion of the protocol.
11. Current use of MAO Inhibitor or use within the past two weeks.
12. Investigator and his/her immediate family defined as the investigator's spouse,
parent, child, grandparent, or grandchild.
18 Years to 55 Years
Accepts Healthy Volunteers
Study Locations and Contact Information (1)
|Massachusetts General Hospital - Boston, Massachusetts||2.8 miles||Lauren Rhodewalt BSemail@example.com|