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

NCT ID: NCT01853280

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

L-Methylfolate

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

Group Type: EXPERIMENTAL

L-methylfolate

Intervention Type: DRUG

15mg/day L-methylfolate.

OROS-Methylphenidate

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

OROS-Methylphenidate

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Interventions

L-methylfolate

15mg/day L-methylfolate.

Intervention Type: DRUG

OROS-Methylphenidate

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Deplin®; Concerta®

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamlab, Inc.

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Craig B. Surman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig Surman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2012-P-000379

Identifier Type: -

Identifier Source: org_study_id