The treatment of sleep disorders in patients with autism spectrum disorders (ASD)
Conditions
Interventions
Trade Name: Valdoxan 25mg
Product Name: Agomelatine
Pharmaceutical Form: Tablet
INN or Proposed INN: AGOMELATINE
CAS Number: 138112-76-2
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Hospital General Universitario de Alicante
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the efficacy of agomelatine in improving the quantity and quality of sleep in patients with ASD as recorded by an integrated variable TAP.;Secondary Objective: Analysis of (1) safety and tolerability of agomelatine in ASD, (2) Expression of clock genes and the presence of genetic variants in the way melatonergic, (3) Correlation of clinical variables (sleep logs and questionnaires), hormonal (cortisol and melatonin) and genetic (4) Analysis of a combination of variables that may predispose to associate better pharmacological response to agomelatine.;Primary end point(s): Determination of the TAP variable [TAP = ((1-T) + A + P) / 3 where 0 corresponds to total relaxation and sleep, and 1 busy periods] *. * Calculated as described by Ortiz-Tudela et al. (2011): a) Record the temperature (T) by a sensor programmed to measure every 10 minutes on the wrist. Naturally, the temperature of the doll has the highest values ??when the subject is asleep and the lowest for the day when awake, while the opposite is true in the case of motor activity and body position. Therefore, be invested temperature values ??for the maximum values ??of the 3 variables at the same time match of the day, b) actímetro (A) on the biceps of the subject, you can record the acceleration of the axes X, Y and Z readings static position. The sensor is programmed to record data every 30 seconds and define two variables: motor activity (A, expressed as degrees of change in position, being the sum of the first derivative of the angle between the normal position and the position sensor 30 s advance taking into account the X, Y and Z), c) body position (P, calculated as the angle between the axis X of A and a horizontal plane, ranging from 0 ° horizontal and 90 ° vertical high maximum). The information stored in the records are transferred to a computer and will be reviewed by the team of Dr. Madrid (see financial report).;Timepoint(s) of evaluation of this end point: one week, one | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Analysis of the expression of clock genes (Per1, period 1, NPAS2, neuronal PAS domain protein 2) by qPCR and analysis of the presence of genetic variants by Rotor-Gene on the road melatonergic (ASMT receptors and melatonin receptors 1A and 1B (MTNR1A, B) [c.-376G> A, C-38C> T and IVS5 +2 T> C in ASMT, c.-158c> T and c.370G MTNR1A> A and c.-39 GC > MTNR1B AA] (Johsson et al., 2010). Determinations hormone melatonin (09:00 AM and 11 PM) and cortisol (9AM) before and after each period (Brzezinski, 1997) in saliva to be held in the Clinical Analysis Laboratory HGUA. Correlation of clinical variables (sleep diaries and questionnaires): Sleep Quality Index in Pittsburgh, Epworth Sleepiness Scale, Assessment-Questionnaire SMAG adherence to compliance, assessment, quality of life questionnaire SF-30 MOS-, Scale, Hospital Anxiety and Depression (HADS), hormonal (melatonin and cortisol) and genetics. Analysis of a combination of variables that may predispose to associate better pharmacological response to agomelatine.;Timepoint(s) of evaluation of this end point: 3 times | — |
Countries
Spain
Contacts
Public ContactFundación Investigación HGUA
Hospital General Universitario de Alicante
Outcome results
None listed