Efficacy of metadoxine extended release in patients with predominantly inattentive subtype attention-deficit/hyperactivity disorder.
OBJECTIVE
To compare the effects of metadoxine extended release (ER) with those of placebo on inattentive (IA) versus hyperactive-impulsive (H-I) symptoms and predominantly inattentive (PI) versus combined type (CT) subtype in adults with attention-deficit/hyperactivity disorder (ADHD).


METHODS
This was a 1:1 randomized, double-blind, parallel-design study of metadoxine ER 1400 mg/day for 6 weeks in 120 adults with ADHD. Efficacy measures were baseline to end-of-treatment changes in Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) Total ADHD Symptoms scores with adult ADHD prompts, the Test of Variables of Attention ADHD scores, and response rates (≥ 25% or ≥ 40% improvement in CAARS-INV Total ADHD Symptoms score).


RESULTS
There was a significant decrease in CAARS-INV Total ADHD Symptoms scores in patients with ADHD-PI taking metadoxine ER (40%) compared with those taking placebo (21%) (P < 0.05), while the decrease for patients with ADHD-CT was not significant (27% vs 26%). Similarly, there was a significant decrease in IA scores in patients with ADHD-PI (metadoxine ER, 50% vs placebo, 23%; P < 0.005), while the change in patients with ADHD-CT was not significant. There was no significant difference in percent decreases seen in H-I scores for patients with PI or ADHD-CT. Significantly higher response rates at both cutoffs (ie, 25% and 45% improvement) were seen in the metadoxine ER group compared with the placebo group in CAARS-INV Total ADHD Symptoms scores in patients with ADHD-PI, but not those with ADHD-CT. Test of Variables of Attention ADHD scores were significantly decreased in the metadoxine ER group compared with the placebo group for patients with ADHD-PI, but not those with ADHD-CT.


CONCLUSIONS
These data suggest that metadoxine ER is selectively efficacious for treating IA symptoms in adults with ADHD-PI.


BACKGROUND
www.ClinicalTrials.gov identifier NCT01243242.
Geha Mental Health Center, Petach Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Iris
I
Manor
Jeffrey H
JH
Newcorn
Stephen V
SV
Faraone
Lenard A
LA
Adler
D000293:Adolescent; D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000145:classification / Q000188:drug therapy*; D002491:Central Nervous System Agents / Q000627:therapeutic use*; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011581:Psychological Tests; D011736:Pyridoxine / Q000627:therapeutic use*; D011761:Pyrrolidonecarboxylic Acid / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D002491:Central Nervous System Agents; D003692:Delayed-Action Preparations; D004338:Drug Combinations; C037845:metadoxine; D011736:Pyridoxine; D011761:Pyrrolidonecarboxylic Acid