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NCT01853280 · ClinicalTrials.gov registry record · Phase 2
L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT01853280: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT01853280 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01853280, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG OROS-Methylphenidate
- DRUG L-methylfolate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-09 |
| Phase | Phase 2 |
What the finished NCT01853280 record still lists
NCT01853280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01853280 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01853280 about?
NCT01853280 is a clinical study titled "L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults". 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-...
What is the current status of trial NCT01853280?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2014-05. Estimated completion is 2017-09.
What interventions are being tested in trial NCT01853280?
The interventions under investigation include: Placebo (DRUG), OROS-Methylphenidate (DRUG), L-methylfolate (DRUG).
Who is sponsoring clinical trial NCT01853280?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01853280's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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