Efficacy and safety of memantine as antimanic and mood-stabilizing medication for adolescents with Bipolar Disorder: a monocentric, randomized, double-blind, placebo-controlled clinical trial.

Bipolar Disorder

Improvement of manic symptoms by the mean change in YMRS total score from intake to week 12

Time-to-dropout from the AAT phase (days from start of experimental treatment to the start of aripiprazole add-on treatment) in memantine vs placebo arm, Response of [hypo]manic or mixed episodes by week 12, assessed by evaluating the percentage of subjects given memantine vs placebo showing a response of manic or mixed episodes as reduction by <=50% of the total YMRS score after 12 weeks of treatment., Pct of subs completing the52-wk study andwith remission of sx measured by the combo:-Pct of pts withCGIBP improv score<=2;-Pct of pts with a reduction of>=50% at total YMRS score and CDRS-R score;-Pct of pts with aYMRS totscore<=12,aCDRS-Rtotscore<=28and aCGI-BPseverityscore<=2;-Pct of pts needing aripiprazole in add-on to the ongoing exp tx,avg duration of add-on tx and the avg dailydose needed in memantinevsplaceboarm for the52-wk, Percentage of subjects showing improvement at the 52-week study as measured by the following outcomes: a. Percentage of patients completing the 52 weeks of the study in memantine versus placebo group; b. Significant superior increased C-GAS score in memantine vs placebo group., Safety and tolerability parameters will be evaluated by recording all adverse events (AEs) and serious adverse events (SAEs)

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