ovel avenues for the rescue of intellectual disability in Down syndrome
- Conditions
- DOWN SYNDROMEMedDRA version: 20.0Level: LLTClassification code 10042801Term: Syndrome Down'sSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-000687-16-IT
- Lead Sponsor
- AOU FEDERICO II
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
- Subjects of either gender with Down syndrome aged between 5 and 10, extremes included;
- Subjects who gave their consent to participate to the study by informed consent signature from parents or legal tutors before any data collection;
- Subjects in euthyroidism (reference value: FT4) with or without drug therapy;
- Subjects, celiac or not, with negative values at screening for celiac disease (reference value: Antitransglutaminase antibodies IgA);
- Subjects who never took fluoxetine previously.
- Patients not treated with contraindicated concomitant therapies
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
- Subjects aged less than 5 or more than 10;
- Subjects with concomitant neurological diseases other than those expected for the Down syndrome phenotype;
- Subjects with neuropsychiatric diseases: Depressive and Bipolar Disorders;
- Subjects with major malformations requiring prolonged hospitalization;
- Subjects with concomitant medical conditions such as: epilepsy, thyroid dysfunction (not in euthyroidism), diabetes, gastrointestinal,
hepatic or renal problems that may alter the absorption and the metabolism of the experimental drug; patients with bleeding disorders or history of bleeding disorders;
- Subjects with long QT syndrome and/or familiarity of long QT syndrome;
- Subjects with congenital cardiopathy, nocturnal apnea syndrome, pericarditis and myocarditis, hypertension or hypertensive crisis,
blood electrolytes alterations (in particular, potassium and calcium);
- Subjects treated with controindicated concomitant therapies:
Reversibile and irreversibile monoamine oxidase inhibitor: MAOI-A and MAOI-B (selegiline);
Oral anticoagulants, drugs known to affect platelet function (e.g. atypical antipsychotics such as clozapine, phenothiazines, tricyclic antidepressants, aspirin, nonsteroidal anti-inflammatory drugs NSAID’s) or other drugs that may increase risk of bleeding;
Electroconvulsive Therapy (ECT);
St John’s Wort (Hypericumperforatum);
Serotonergic (such as L-tryptophan, tramadol, triptans) and/or neuroleptic drugs;
Phenytoin;
Lithium and tryptophan;
Drugs metabolised by the CYP2D6 isoenzyme: because fluoxetine’s metabolism (like tricyclic antidepressants and other selective serotonin antidepressants) involves the hepatic cytochrome CYP2D6 isoenzyme system, concomitant therapy with drugs also metabolised by this enzyme system may lead to drug interactions. Concomitant
therapy with drugs predominantly metabolised by this isoenzyme, and which have a narrow therapeutic index (such as risperidone, atomoxetine, metaprolol, tamoxifene, flecainide, encainide,
carbamazepine and tricyclic antidepressants), will be not allowed. This will also apply until 5 weeks from fluoxetine withdrawal.
Alcohol
Drug determining a prolonged QT-interval such as class IA and III antiarrhythmic agents, antipsychotic drugs (phenothiazine derivatives, pimozide, aloperidole, tricyclic antidepressant, antibacterial agents (sparfloxacine, moxifloxacine, eritromicine IV, pentamidine, antimalaric drugs (alofantrina) and antihistamine agents (astemizole, mizolastine).
Benzodiazapines. Plasma concentrations of diazepam and alprazolam can increase when fluoxetine is administered in combination.
Antipsychotics. Possible pharmacodynamic and/or pharmacokinetic interaction between SSRIs and antipsychotics. Elevation of blood levels of haloperidol and clozapine has been observed in patients receiving concomitant Fluoxetine.
Anticonvulsants. Patients on stable doses of phenytoin and carbamazepine have developed elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation
of concomitant Fluoxetine treatment.
Drugs Tightly Bound to Plasma Proteins. Because Fluoxetine is tightly bound to plasma proteins, the administration of Fluoxetine to a patient taking another drug that is tightly bound to protein (digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect.
- Subjects taking one or more of the following: B12 vitamins, folates, minerals (selenium, zinc, and magnesium), gingko biloba, cur
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate safety and tolerability of fluoxetine in a pediatric population with Down syndrome;Secondary Objective: To evaluate the efficacy of fluoxetine in ameliorating cognitive performances in children with Down syndrome by measuring improvements of at least one of the hippocampus-connected functions namely: memory, attention and learning skills, visuo-spatial processing function.;Primary end point(s): To evaluate safety and tolerability of fluoxetine in a pediatric population with Down syndrome;Timepoint(s) of evaluation of this end point: Screening, T0, T+1 month, T+3 month, T+6 month, T++6 month, T+12 month
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To evaluate the efficacy of fluoxetine in ameliorating cognitive performances in children with Down syndrome by measuring improvements of at least one of the hippocampus-connected functions namely: memory, attention and learning skills, visuo-spatial processing function.;Timepoint(s) of evaluation of this end point: T0, T+6 month, T+12 month