drugset / Trial / NCT01853280

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

NCT01853280

Phase 2/3 Completed 47 enrolled Massachusetts General Hospital Pamlab, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2014-05
Primary completion
2017-02
Completion
2017-09

Drugs

EvaluationDrugModalityDoseRoute
Subject L-methylfolate Unknown 15 mg
Background Methylphenidate Small molecule