L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

This pilot study seeks to evaluate initial evidence for the effect of L-methylfolate supplementation to OROS-Methylphenidate pharmacotherapy on ADHD symptoms and associated features in adults with ADHD, as well as tolerability of this supplementation. The investigators will conduct a 12-week double-blind randomized placebo-controlled trial with L-methylfolate supplementing open-label OROS-Methylphenidate (OROS-MPH). The investigators propose to examine 40 adult (ages 18-55) subjects satisfying the DSM-IV diagnostic criteria for ADHD.

Key facts

Study ID

NCT01853280

Run by

Massachusetts General Hospital

People needed

47

Starts

2014-05-01

Expected to finish

2017-09-01

Last updated by the study team

2017-11-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female adults ages 18-55 years of age.
• 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 (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.
• A score of 24 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS).

You may not qualify if…

• A history of non-response or intolerance to methylphenidate at adequate doses as determined by the clinician.
• A history of intolerance to L-methylfolate supplementation.
• Pregnant or nursing females.
• Serious, unstable medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic (thyroid), neurologic (seizure), immunologic, or hematologic disease.
• Glaucoma.
• Clinically unstable psychiatric conditions including suicidality, homicidality, bipolar disorder, psychosis, history of or current marked anxiety, tension or agitation potentially exacerbated by a stimulant, or lifetime history of any other clinically serious condition potentially exacerbated by a stimulant, such as mania or psychosis.
• Significant impairment due to tics, based on clinician judgment.
• A family history or diagnosis of Tourette's syndrome
• Current (within 3 months) DSM-IV criteria for abuse or dependence with any psychoactive substance other than nicotine.
• Multiple adverse drug reactions.
• Any other concomitant medication considered to be effective for management of ADHD; individuals on stable treatment with agents with central nervous system activity will be allowed to participate, as detailed in the Concomitant Medication portion of the protocol.
• Current use of MAO Inhibitor or use within the past two weeks.
• Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
• Use of supplemental folic acid greater than 400 mcg per day, L-methylfolate, or Omega-3 Fatty Acids greater than 800 mg per day within two weeks prior to the baseline study visit.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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