CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 47 enrolled
Drug / intervention
L-methylfolate +2 moredrug
Likely dose
L-methylfolate 15mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01853280
NCT01853280Phase 3Completed
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L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial

Massachusetts General Hospital·interventional·Posted May 14, 2013·Updated Nov 14, 2017

In Brief

A Phase 3 clinical trial evaluating L-methylfolate, OROS-Methylphenidate, and 1 other intervention for Attention Deficit Hyperactivity Disorder. Completed, enrolled 47 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
CollaboratorsPamlab, Inc.

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 14, 2013
Enrollment StartMay 1, 2014
Primary CompletionFeb 1, 2017
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.1 years ago

Interventions

L-methylfolatedrug

15mg/day L-methylfolate.

OROS-Methylphenidatedrug

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

Placebodrug

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