DOWN SYNDROME MedDRA version: 20.0 Level: LLT Classification code 10042801 Term: Syndrome Down's System Organ Class: 100000004850
Conditions
Interventions
Trade Name: PROZAC - 20 MG/5 ML SOLUZIONE ORALE 1 FLACONE IN VETRO DA 60 ML
Product Name: prozac
Product Code: 25970029
Pharmaceutical Form: Oral solution
INN or Proposed INN: FLUOXETINA CLORIDRATO
C
Sponsors
AOU FEDERICO II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactDipartimento di Pediatria
Dipartimento di Scienze Mediche Traslazionali- sez. di Pediatria
Outcome results
None listed