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

Description

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

May 2014

Estimated Completion Date

May 2016

Interventions

  • Drug: OROS-Methylphenidate
  • Drug: Placebo
  • Drug: L-methylfolate

Specialties

  • Psychiatry: Neuro/Psych Pharmacol,Other Psychiatry
  • Pharmacy: Drug Trials,Neuro/Psych pharmacology

MeSH Terms

  • Attention Deficit Disorder with Hyperactivity

Study ID

Massachusetts General Hospital -- 2012-P-000379

Status

Unknown

Trial ID

NCT01853280

Study Type

Interventional

Trial Phase

Phase 2/Phase 3

Enrollment Quota

40

Sponsor

Massachusetts General Hospital

Inclusion Criteria

    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).

Exclusion Criteria

    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. 5. Glaucoma. 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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Lauren Rhodewalt BS 617-643-1432 lrhodewalt@mgh.harvard.edu

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