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

Phase 1

• Conditions: Bipolar Disorder; MedDRA version: 21.1Level: PTClassification code 10057667Term: Bipolar disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-002778-30-IT
• Lead Sponsor: IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-22
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 68

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

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 <70), organic mental disorder, or mental disorder due to a general medical condition or substance abuse (DSM-5 criteria);
5) comorbid DSM-5 diagnosis of Substance Abuse Disorder;
6) a serious or unstable general medical illness or clinically significant abnormal vital signs or ECG abnormality;
7) known hypersensitivity to the active substance or to any of the excipients;
8) patient with severe renal impairment (glomerular filtration rate, GFR, < 89 mL/min. GRF 89–60 mL/min: damage with minimal loss of renal function), accoding to Schwartz Equation;
9) 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);
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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.