Effects of the antidepressive therapy with Agomelatin and Escitalopram in people with depression and epilepsy

Phase 1

• Conditions: Depression in patients affected by epilepsy; MedDRA version: 20.0 Level: LLT Classification code 10032061 Term: Other forms of epilepsy System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-000990-35-IT
• Lead Sponsor: DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-14
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 208

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;<br> 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;<br> •To evaluate the effects of AGO on subjective sleep quality as compared to escitalopram;<br> •To evaluate the effects of AGO on excessive daytime somnolence as compared to escitalopram;<br> •To evaluate the effects of AGO on cognition as compared to escitalopram.<br> ;Primary end point(s): Efficacy (Depression BDI-II);Timepoint(s) of evaluation of this end point: 30 months

Secondary Outcome Measures

Name	Time	Method
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