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

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ClinicalTrials.gov Identifier: NCT01853280
Recruitment Status : Completed
First Posted : May 14, 2013
Results First Posted : November 14, 2017
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
Pamlab, Inc.
Information provided by (Responsible Party):
Craig B. Surman, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: L-methylfolate Drug: OROS-Methylphenidate Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial
Study Start Date : May 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: L-Methylfolate
15 mg of L-Methylfolate (Deplin®) daily for 12 weeks as a supplement to OROS-Methylphenidate.
Drug: L-methylfolate
15mg/day L-methylfolate.
Other Name: Deplin®

Drug: OROS-Methylphenidate
All subjects will be treated with open-label OROS-MPH
Other Name: Concerta®

Placebo Comparator: Placebo
15 mg matched placebo comparator, with open-label OROS-Methylphenidate
Drug: OROS-Methylphenidate
All subjects will be treated with open-label OROS-MPH
Other Name: Concerta®

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




Primary Outcome Measures :
  1. Adult ADHD Investigator Symptom Rating Scale (AISRS) [ Time Frame: 12 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (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, 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.
  7. Significant impairment due to tics, based on clinician judgment.
  8. A family history or diagnosis of Tourette's syndrome
  9. Current (within 3 months) DSM-IV criteria for abuse or dependence with any psychoactive substance other than nicotine.
  10. Multiple adverse drug reactions.
  11. 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.
  12. Current use of MAO Inhibitor or use within the past two weeks.
  13. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
  14. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853280


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Pamlab, Inc.
Investigators
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Principal Investigator: Craig Surman, MD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Craig B. Surman, MD, Massachusetts General Hospital:
Study Protocol  [PDF] November 21, 2016
Statistical Analysis Plan  [PDF] December 22, 2016


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Responsible Party: Craig B. Surman, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01853280     History of Changes
Other Study ID Numbers: 2012-P-000379
First Posted: May 14, 2013    Key Record Dates
Results First Posted: November 14, 2017
Last Update Posted: November 14, 2017
Last Verified: October 2017
Keywords provided by Craig B. Surman, MD, Massachusetts General Hospital:
ADHD
Attention Deficit Hyperactivity Disorder
Deplin
L-methylfolate
Natural Treatments
Medical Food
Additional relevant MeSH terms:
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Methylphenidate
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Tetrahydrofolates
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances