Depression in patients affected by epilepsy MedDRA version: 20.0 Level: LLT Classification code 10032061 Term: Other forms of epilepsy System Organ Class: 100000004852
Conditions
Interventions
Trade Name: VALDOXAN - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/PVC) 7 COMPRESSE
Product Name: Agomelatina
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: n.a.
Con
Sponsors
DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Definite diagnosis of epilepsy and antiepileptic medication for more than 6 months; 2. Age 40-75; 3. Beck Depression Inventory –II score >14 4. No previous utilization of any antidepressant agent; 5. Able to co-operate and understand written and oral information; 6. Signed written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 134 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 88
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity to the Agomelatine and/or Escitalopram; 2. Psychiatric disorders other than depression; 3. Participation in other clinical trials within the last six months prior to inclusion in the present study; 4. Unable to take part in the study as a whole; 5. Use of drugs interfering with CNS other than AEDs; 6. History of pseudoseizures, status epilepticus during the previous year; 7. Alterations of blood tests that might interfere with the participation and/or completion of the study by the patient; 8. Patients with hepatic injury, or with transaminases levels three times the upper limit of normal (ULN), or hepatic risk factors such as obesity/overweight/non-alcoholic fatty liver disease, diabetes, substantial alcohol intake or concomitant medicinal products associated with risk of hepatic injury. 9. Concomitant treatment based on strong CYP1A2 inhibitors; 10. Women of childbearing potential who are not using effective contraception; 11. Women with suspected or confirmed pregnancy and breastfeeding; 12. Concomitant hormonal therapy; 13. QTc interval>450 msec.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effects of AGO on depressive symptoms of PWE as compared to escitalopram as active control.;Secondary Objective: •To evaluate the quality of life and seizure frequency in order to test the actual relationship between depressive symptoms and seizure control and to test the hypothesis of a “melatoninergic” additive effect of AGO on depression and seizures frequency when compared to escitalopram as active control; •To evaluate the effects of AGO on subjective sleep quality as compared to escitalopram; •To evaluate the effects of AGO on excessive daytime somnolence as compared to escitalopram; •To evaluate the effects of AGO on cognition as compared to escitalopram. ;Primary end point(s): Efficacy (Depression BDI-II);Timepoint(s) of evaluation of this end point: 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Depression (HDRS), Quality of life (Qolie-31P, Quality of Life in Epilepsy II Version), Sleep quality (PSQI), daytime sleepiness (ESS) and cognition (MDB).;Timepoint(s) of evaluation of this end point: 30 months | — |
Countries
Italy
Contacts
Public ContactClinical Operations
Link Neuroscience and health care s.r.l. - L.N.Age s.r.l.
Outcome results
None listed