Adults (over 30 years) with Down Syndrome. MedDRA version: 14.1 Level: LLT Classification code 10040442 Term: Severe imbecility System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: FLUOXETINE
CAS Number: 54910-89-3
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
IRCCS FONDAZIONE STELLA MARIS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria are: 1) SD 2) subjects of both sexes and older than 30 years 3) signing of informed consent by the parent or legal tutor of the patient. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: Exclusion criteria are: 1) the presence of clinical signs of dementia at the first valuation, 2) drugs that may interact with fluoxetine (Monoamine Oxidase, Phenytoin, serotonergic drugs, lithium and tryptophan, oral anticoagulants, Electroconvulsive Therapy, drugs that interact with the CYP2D6 isoenzyme system in the liver), 3) medical conditions that are contraindicated for treatment with fluoxetine (Mania, Hepatic and renal failure, diabetes, Akathisia / psychomotor restlessness, bleeding disorders, epilepsy), 4) established pregnancy (the pregnancy will be investigated in females of childbearing age through the declaration of the person and / or tutor).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the project is to determine the effects of environmental enrichment and intervention of fluoxetine after 6 months of the start of the intervention (training or treatment with fluoxetine): i) to prevent cognitive and functional impairment through behavioral tests and questionnaires standardized ii) to change structural neurobiological (brain MRI) and functional (EEG) indices in subjects with DS over 30 years.;Secondary Objective: Secondary objectives of the study are: 1. Determine the health and quality of life, through standardized instruments, of adults with DS older than 30 years in Tuscany and to develop a regional database with the data obtained 2. Determine the compliance to the enrichment intervention into the study group and just in case of positive results the treatment protocol will be expanded to all adults with DS in Tuscany.;Primary end point(s): Percentual variation of each parameter which has been evaluated.;Timepoint(s) of evaluation of this end point: Six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Italy
Contacts
Public ContactStefania Bargagna
IRCCS Stella Maris
Outcome results
None listed