Efficacy and safety of agomelatine (25mg/day with blinded potential adjustment to 50mg/day) versus escitalopram (10mg/day with blinded potential adjustment to 20mg/day) given orally for 12 weeks in non-depressed out-patients with severe Generalized Anxiety Disorder. A 12-week randomised, double-blind, versus escitalopram, 2-arm parallel groups, international multicenter study with a 9-month extension period

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003699-37-CZ

Enrollment

510

Registered

2012-11-28

Start date

2013-01-17

Completion date

Unknown

Last updated

2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder MedDRA version: 14.1 Level: PT Classification code 10018075 Term: Generalised anxiety disorder System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: VALDOXAN Product Name: S20098 Product Code: S20098 Pharmaceutical Form: Capsule INN or Proposed INN: AGOMELATINE CAS Number: 138112-76-2 Current Sponsor code: S20098 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -All patients selected will be aged between 18 (or legal age for majority in the country) and 65 years old inclusive, male or female, out-patients. -fulfilling DSM-IV-TR criteria for Generalized Anxiety Disorder confirmed by the M.I.N.I. structured interview and requiring a psychotropic treatment. 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 510 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Patients with current anxiety disorders other than Generalized Anxiety Disorder according to DSM IV criteria. -Pregnant or breastfeeding women, -Women of childbearing potential without effective contraception (i.e. contraceptive pill, surgical sterilization, hormonal contraceptive injections, intra-uterine contraceptive device, contraceptive implant, patch or condom). Please note that vasectomy of the partner is not considered as an effective contraception method for the patient in the framework of clinical studies, -Patients not able to read and/or write, -Patients who have a suicide risk according to the investigator's judgment; or with a score > 3 on the MADRS item X or who have made a suicide attempt within the past year.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of agomelatine compared to escitalopram after a 12-week treatment in non-depressed out-patients suffering from severe Generalized Anxiety Disorder (GAD). ;Secondary Objective: -to further describe the effects on anxiety symptoms, on daytime alertness, on subjective sleep, on anhedonia. -to provide additional long-term efficacy data of agomelatine -to provide additional safety and tolerability data on agomelatine. -to evaluate the influence of genetic factors on efficacy and safety of agomelatine in a pharmacogenetic sub-study. ;Primary end point(s): HAM-A total score.;Timepoint(s) of evaluation of this end point: All over the study	—

Measure

Time frame

Main Objective: To assess the efficacy of agomelatine compared to escitalopram after a 12-week treatment in non-depressed out-patients suffering from severe Generalized Anxiety Disorder (GAD). ;Secondary Objective: -to further describe the effects on anxiety symptoms, on daytime alertness, on subjective sleep, on anhedonia. -to provide additional long-term efficacy data of agomelatine -to provide additional safety and tolerability data on agomelatine. -to evaluate the influence of genetic factors on efficacy and safety of agomelatine in a pharmacogenetic sub-study. ;Primary end point(s): HAM-A total score.;Timepoint(s) of evaluation of this end point: All over the study

—

Secondary

Measure	Time frame
Secondary end point(s): -HAM-A score -CGI-S and CGI-I scores -Toronto Hospital Alertness Test (THAT) total score -Leeds Sleep Evaluation Questionnaire (LSEQ) scores -Snaith-Hamilton Pleasure Scale (SHAPS) total score ;Timepoint(s) of evaluation of this end point: All over the study	—

Countries

Australia, Canada, Czech Republic, Finland, Germany, Hungary, Poland, Russian Federation, Slovakia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026