Efficacy and safety of 2 dose regimens of agomelatine (10 mg/day or 25 mg/day) versus placebo given orally for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder

Efficacy and safety of 2 doses of agomelatine (10 mg/day or 25 mg/day) versus placebo given orally for 12 weeks in non depressed out-patients with Generalized Anxiety Disorder. A 12-week randomised, double-blind, placebo-controlled, 3-arm parallel groups, international multicenter study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001666-15-FI

Enrollment

390

Registered

2013-04-25

Start date

2013-06-11

Completion date

Unknown

Last updated

2015-02-16

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: 17.0 Level: LLT Classification code 10018105 Term: Generalized anxiety disorder System Organ Class: 100000004873

Interventions

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 milligram(s) Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - All patients selected will be aged 18 (or legal age for majority in the country) and over, 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 370 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

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 demonstrate the short-term efficacy of at least one of the 2 dose regimens of agomelatine (versus placebo) using HAM-A scale after a 12-week treatment period in non-depressed out-patients suffering from Generalized Anxiety Disorder (GAD). ;Secondary Objective: The secondary objectives are: - to assess the short-term efficacy on anxiety symptoms, global improvement and social functioning - to provide additional safety and tolerability data on agomelatine ;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 demonstrate the short-term efficacy of at least one of the 2 dose regimens of agomelatine (versus placebo) using HAM-A scale after a 12-week treatment period in non-depressed out-patients suffering from Generalized Anxiety Disorder (GAD). ;Secondary Objective: The secondary objectives are: - to assess the short-term efficacy on anxiety symptoms, global improvement and social functioning - to provide additional safety and tolerability data on agomelatine ;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): • Anxiety symptoms: - HAM-A Psychic anxiety sub-score - HAM-A Somatic anxiety sub-score - CGI-S and CGI-I scores - Hospital Anxiety and Depression scale (HAD): • Social functioning: - Sheehan Disability Scale (SDS) score • Safety criteria ;Timepoint(s) of evaluation of this end point: All over the study	—

Countries

Argentina, Finland, Poland, Russian Federation, Slovakia, Ukraine

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33 1 55 72 43 66

Outcome results

None listed

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