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

NCT01853280 | Completed Phase 2 Results

• 1 other identifier: 2012-P-000379
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Attention Deficit Hyperactivity Disorder; Deplin; L-methylfolate; Natural Treatments; Medical Food

Outcome Measures

Primary Outcomes (1)

• Adult ADHD Investigator Symptom Rating Scale (AISRS)

  The AISRS is an 18-item questionnaire administered by the clinician assessing each of the individual DSM-IV symptoms of ADHD. Each symptom is rated on a scale of severity from 0 (none) to 3 (severe), and the 18 symptom questions are summed to calculate a total score. The minimum total score is a 0, while the maximum total score is a 54. The AISRS was compared from baseline to completion, over the course of the 12 week study.

  12 weeks

Study Arms (2)

L-Methylfolate

EXPERIMENTAL

15 mg of L-Methylfolate (Deplin®) daily for 12 weeks as a supplement to OROS-Methylphenidate.

Drug: L-methylfolate; Drug: OROS-Methylphenidate

Placebo

PLACEBO COMPARATOR

15 mg matched placebo comparator, with open-label OROS-Methylphenidate

Drug: OROS-Methylphenidate; Drug: Placebo

Interventions

L-methylfolate DRUG

15mg/day L-methylfolate.

Also known as: Deplin®

L-Methylfolate

OROS-Methylphenidate DRUG

All subjects will be treated with open-label OROS-MPH

Also known as: Concerta®

L-Methylfolate; Placebo

Placebo DRUG

15 mg matched placebo comparator, with open-label OROS-Methylphenidate

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Pamlab, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

5-methyltetrahydrofolate; Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Craig Surman
• Organization: Massachusetts General Hospital

csurman@partners.org

617-726-8422

Study Officials

• Craig Surman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 14, 2013
• Study Start: May 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 14, 2017
• Results First Posted: November 14, 2017

Record last verified: 2017-10

Locations

US (1)