Bipolar Disorder MedDRA version: 21.1 Level: PT Classification code 10057667 Term: Bipolar disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: MEMANTINA ACCORD - 10 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PE/PVDC/ALLUMINIO) - 56 COMPRESSE
Product Name: MEMANTINA ACCORD
Product Code: [NA]
Pharmaceutical Form:
Sponsors
IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) either sex, aged 13-17 years at baseline; 2) 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 School-aged Children, Present and Lifetime version [K-SADS-PL]); 3) YMRS total score of 20-40 at baseline; 4) CGI-BP severity score of 4-6 at baseline; 5) providing assent to participate and signed consent by a parent or legal representative; 6) girls deemed to be of reproductive potential, must have a confirmed negative urine pregnancy test at intake, and use adequate contraception throughout the study. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) YMRS item 8 (delusions; hallucinations) score = 8; 2) 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; 3) 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; 4) intellectual disability (IQ = 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); 10) 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, Wolf-Parkinson-White (WPW), ventricular fibrillation, ventricular tachycardia, Brugada syndrome, severe Sinus bradycardia FC<40 bp/m).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of memantine versus placebo in improving manic symptoms in adolescents meeting standard diagnostic criteria for BD.;Secondary Objective: To compare the effect of memantine versus placebo as a mood-stabilizing agent for adolescents with BD.;Primary end point(s): Improvement of manic symptoms by the mean change in YMRS total score from intake to week 12.;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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).; 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% at total YMRS score and a reduction of >=50% at total CDRS-R score c. Percentage of patients showing remission of manic and depressive episodes as defined by a YMRS total score <=12, a CDRS-R total score <=28 and a CGI-BP severity score <=2 d. Percent of patients needing aripiprazole in add-on to the ongoing experimental treatment, average duration of add-on treatment and the average daily dose needed in memantine versus placebo arm during the 52-week study.;Timepoint(s) of evaluation of this end point: At week 52; At week 52; At week 12; After 12 weeks of treatment; At week 52 | — |
Countries
Italy
Contacts
Public ContactNeurospichiatria Infantile
Ospedale Pediatrico Bambino Gesù
Outcome results
None listed