Double-blind, randomized, monocentric study to evaluate the efficacy and safety of memantine in adolescents with Bipolar Disorder

Trial details

Who runs it

Ospedale Pediatrico Bambino Gesu

Trial code

EU 2024-516713-21-00

Record updated

2024. november 11.

Original description

To compare the effect of memantine versus placebo in improving manic symptoms in adolescents meeting standard diagnostic criteria for BDRead full original descriptionShow less

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.

To compare the effect of memantine versus placebo in improving manic symptoms in adolescents meeting standard diagnostic criteria for BD

Inclusion: either sex, aged 13-17 years at baseline; DSM-5 diagnosis of BD (Type I, Type II, Cyclothymic Disorder, Unspecified) with mild to moderate symptom-severity, with current manic, mixed, or hypomanic symptoms (not psychotic) based on expert clinical assessment confirmed with structured diagnostic assessment (with Kiddie-Schedule for Affective Disorders and Schizophrenia for Schoolaged Children, Present and Lifetime version [K-SADS-PL]); YMRS total score of 20-40 at baseline; CGI-BP severity score of 4-6 at baseline; providing assent to participate and signed consent by a parent or legal representative; girls deemed to be of reproductive potential, must have a confirmed negative urine pregnancy test at intake, and use adequate contraception throughout the study.

Exclusion: exposure to any medicine that can interfere with assessments of safety, tolerability, or efficacy of memantine or placebo, or with the conduct/interpretation of the study; specifically: antipsychotic-antimanic agents including haloperidol, risperidone, quetiapine, aripiprazole, olanzapine, ziprasidone, carbamazepine, lamotrigine, valproate, and antidepressants; ketamine or other NMDA antagonists in last the month prior to enrolment; patient with serious forms of cardiovascular disease (severe and moderate congenital heart disease: severe and moderate ventricular septal defect, severe and moderate atrial septal defect, Tetralogy of Fallot, complete Transposition of the Great Arteries; severe and moderate valvular stenosis and prolapses; cardiac hypertrophy,), arrhythmias (atrial fibrillation, Paroxysmal supraventricular tachycardia (PSVT), atrial flutter, WolfParkinson-White (WPW), ventricular fibrillation, ventricular tachycardia, Brugada syndrome, severe Sinus bradycardia FC<40 bp/m); intellectual disability (IQ <70), organic mental disorder, or mental disorder due to a general medical condition or substance abuse (DSM-5 criteria); comorbid DSM-5 diagnosis of Substance Abuse Disorder; a serious or unstable general medical illness or clinically significant abnormal vital signs or ECG abnormality; known hypersensitivity to the active substance or to any of the excipients; patient with severe renal impairment (glomerular filtration rate, GFR < 29 mL/min/1.73 m2); patient with severe hepatic impairment: at least one of the following parameters >= 2 ULM (referred to the range of normality of this age group and judged clinically significant by the investigators/ specialist medical consultant and/or needing medical treatment: alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP) and gamma glutamyl transferase (GGT), bilirubin); YMRS item 8 (delusions; hallucinations) score = 8; significant current risk of suicide (in the opinion of the Investigator or a "yes" response to suicidal ideation questions 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS]) within the last 6 months.

EU CTIS 2024-516713-21-00