Decline of mentale functions in adults with Down Syndrome: clinical and experimental study on the effects of treatment with fluoxetine and of cognitive and physical training.
- Conditions
- Adults (over 30 years) with Down Syndrome.MedDRA version: 14.1Level: LLTClassification code 10040442Term: Severe imbecilitySystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-001556-11-IT
- Lead Sponsor
- IRCCS FONDAZIONE STELLA MARIS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method