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

NCT01853280 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2017-11-14

Study results available
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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

Interventions

DRUG

L-methylfolate

15mg/day L-methylfolate.

DRUG

OROS-Methylphenidate

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Pamlab, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Craig Surman, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-02-28
Completion
2017-09-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01853280 on ClinicalTrials.gov