A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of Extended-Release Metadoxine in Adults With Attention-Deficit/Hyperactivity Disorder
Why is this work in the frame?
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
No Canadian affiliation. An affiliation-only frame — the usual design — would never have seen this work. It is one of the works that make the case for inverting the frame.
The three-model screen
all 1,000 screened works →All three models called this out of scope.
Randomized placebo-controlled drug trial in adult ADHD; a trial, not a study of trials.
This randomized trial evaluates an ADHD treatment and does not study clinical research methods.
Clinical RCT of metadoxine for adult ADHD, not a study of research methods.
Abstract
OBJECTIVE: To evaluate the efficacy, safety, and tolerability of an oral extended-release (ER) formulation of the nonstimulant metadoxine in the treatment of adult attention-deficit/hyperactivity disorder (ADHD). METHOD: This was a 1:1 randomized, double-blind, placebo-controlled, parallel-design, phase 2 study of metadoxine ER 1,400 mg/d treatment for 6 weeks, following a 2-week baseline/screening period, involving 120 adults with DSM-IV-defined ADHD. A follow-up assessment occurred 2 weeks after the trial was completed. Efficacy measures included changes in Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) total ADHD symptoms score with adult ADHD prompts (primary measure), response rates (≥ 25% or 40% improvement in CAARS-INV total ADHD symptom score), Test of Variables of Attention (TOVA) performance, and Adult ADHD Quality of Life (AAQoL) total score. The study was conducted from March 15, 2011, to August 21, 2011. RESULTS: Intent-to-treat analysis revealed that subjects receiving metadoxine ER showed statistically significant improvement in CAARS-INV total ADHD symptoms score (P = .02), higher rate of response (≥ 25% [P = .03] or ≥ 40% [P = .04] improvement) on the CAARS-INV total ADHD symptoms score, and improvement in TOVA score (P = .02) and AAQoL score (P = .01) compared with the placebo group. Improvements in ADHD symptoms (scored by CAARS-INV) were significantly different in subjects treated with metadoxine ER versus placebo as early as 2 weeks following treatment initiation. Metadoxine ER was generally well tolerated, with nausea (17% [10/58] vs 0% [0/59]), fatigue (31% [18/58] vs 27% [16/59]), and headaches (29% [17/58] vs 39% [23/59]) being the most frequently reported adverse effects for the metadoxine ER and placebo groups, respectively. CONCLUSIONS: Findings suggest that metadoxine ER is a well-tolerated and effective treatment for adults with ADHD. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01243242.
Stored with the screening record, where it is evidence for the labels above.
The record
- Venue
- The Journal of Clinical Psychiatry
- Topic
- Attention Deficit Hyperactivity Disorder
- Field
- Medicine
- Canadian institutions
- —
- Funders
- CilagH. Lundbeck A/SUniversity of CambridgeBristol-Myers SquibbEli Lilly and CompanyAstraZenecaYork UniversityMassachusetts General HospitalTeva Pharmaceutical IndustriesTel Aviv UniversitySanofiPfizerMajor League Baseball
- Keywords
- TolerabilityPlaceboNauseaAttention deficit hyperactivity disorderMedicineAdverse effectRating scaleInternal medicinePsychologyPsychiatryDevelopmental psychology
- Has abstract in OpenAlex
- yes