Agomelatine efficacy of the drug to improve sleep problems in autistic people
- Conditions
- The treatment of sleep disorders in patients with autism spectrum disorders (ASD)Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2011-003313-42-ES
- Lead Sponsor
- Hospital General Universitario de Alicante
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients must meet all the following criteria:
1.Adults patients between 18 and 65 years old, of both sexes.
2.Patients diagnosed according ICD-10 criteria for ASD.
3.Patients with sleep handicaps (diagnosed according to ICSD-2), after a month to implement sleep hygiene measures.
From the Center
4.Infanta Leonor of Alicante Patients(outpatient and internal).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients with one or more of the following criteria are NOT eligible to participate in the study:
1.Patients who suffer from: epilepsy, physical disability,
2.Patients treated with psychotropic drugs, treatment with inhibitors of CYP1A2
3.Patients with adverse liver function: transaminases = 1.5 times the normal value.
4.Patients with lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication.
5.Patients suffering intercurrent infections or uncontrolled or severe.
6.Patients undergoing major surgical procedures, biopsies, or those who have had significant traumatic injury 1 month before the study, or scheduled for major surgery.
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