Phase 3
Completed N=44
L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults
Source: ClinicalTrials.gov NCT01853280 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Adult ADHD Investigator Symptom Rating Scale (AISRS) — -22.9; -20.8 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adult ADHD Investigator Symptom Rating Scale (AISRS) |
-22.9; -20.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01853280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.