Memantine efficacy and safety in patients with acute mania associated with bipolar I disorder: a pilot evaluation.
OBJECTIVE
Evaluate the efficacy and tolerability of memantine (20, 30, and 40 mg/d) in the acute treatment of adults with bipolar I disorder hospitalized for mania.


METHODS
This multicenter, open-label, pilot trial included adults with bipolar I disorder (manic or mixed episode, with and without psychotic features). Patients were assigned to 21 days of treatment: cohort 1, 20 mg/d (range, 20-30 mg/d); cohort 2, 30 mg/d (range, 30-40 mg/d); cohort 3, 40 mg/d (range, 30-50 mg/d). Efficacy measures included the Young Mania Rating Scale (YMRS) and the Mania Rating Scale (>or=50% reduction in total score from baseline). The change from baseline was also assessed using the Positive and Negative Syndrome Scale in patients with psychiatric symptoms, Positive and Negative Syndrome Scale-Excited Component, Clinical Global Impression Severity and Improvement scores, and Montgomery Asberg Depression Rating Scale.


RESULTS
A total of 35 patients were enrolled; 33 patients received at least 1 dose of memantine and had at least 1 postbaseline assessment using YMRS. Greatest improvement occurred in cohort 1 where half of the patients responded to memantine based on YMRS and Mania Rating Scale. At day 21, a response was observed in all patient cohorts. Treatment-emergent adverse events were reported in 19 patients (54.3%). The most frequently reported adverse events (>or=4 patients) included constipation, nausea, and headache.


CONCLUSIONS
The response to memantine combined with its tolerability support conducting large-sized randomized controlled trials to investigate further the use of memantine monotherapy in the treatment of mania.
Keck
Paul E
PE
Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati, College of Medicine, Cincinnati, OH, USA.
Hsu
Hai-An
HA
Papadakis
Kelly
K
Russo
John
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D018691:Excitatory Amino Acid Antagonists / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008559:Memantine / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D008875:Middle Aged; D010865:Pilot Projects; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
D018691:Excitatory Amino Acid Antagonists; D008559:Memantine