Status:
COMPLETED
L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Pamlab, Inc.
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
PHASE3
Brief Summary
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 ADH...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01853280
Start Date
May 1 2014
End Date
September 1 2017
Last Update
November 14 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114