Efficacy and safety of agomelatine for 12 weeks in non-depressed out-patients with Generalised Anxiety Disorder.

Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment to 50 mg/day) for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder. A 12-week randomised, double-blind, placebo-controlled, with escitalopram (10 mg/day with potential blinded adjustment to 20 mg/day) as validator, 3-arm parallel groups, international multicenter study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013789-17-FI

Enrollment

390

Registered

2010-01-04

Start date

2010-03-11

Completion date

Unknown

Last updated

2012-03-19

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: 13.1 Level: LLT Classification code 10018105 Term: Generalized anxiety disorder System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: VALDOXAN Product Name: S20098 Product Code: S20098 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: AGOMELATINE CAS Number: 138112762 Current Sponsor code: S20098 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Outpatients aged between 18 (or legal age of majority) and 65 years (inclusive), male or female, fulfilling DSM-IV-TR criteria for GAD diagnosis 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 390 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients suffering of all types of current anxiety disorders other than GAD within 6 months prior to selection Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than GAD within 6 months prior to selection Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women Any relevant clinical abnormality detected during physical examinations, ECG or laboratory tests likely to interfere with the study conduct or evaluations

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To further describe the global clinical benefit, the effect on anxiety symptoms, sleep patterns and social functioning of agomelatine and to provide additional safety and tolerability data on agomelatine.;Primary end point(s): Hamilton Anxiety (HAM-A) total score;Timepoint(s) of evaluation of this end point: From baseline to 12 weeks;Main Objective: To confirm the superiority of agomelatine compared to placebo on anxiety in non-depressed out-patients suffering from GAD	—

Measure

Time frame

Secondary Objective: To further describe the global clinical benefit, the effect on anxiety symptoms, sleep patterns and social functioning of agomelatine and to provide additional safety and tolerability data on agomelatine.;Primary end point(s): Hamilton Anxiety (HAM-A) total score;Timepoint(s) of evaluation of this end point: From baseline to 12 weeks;Main Objective: To confirm the superiority of agomelatine compared to placebo on anxiety in non-depressed out-patients suffering from GAD

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Secondary

Measure	Time frame
Secondary end point(s): 1.Hamilton Anxiety (HAM-A) items 2.Clinical Global Impression Severity (CGI-S) and Clinical Global Impression Improvement (CGI-I) 3.Hospital Anxiety Depression (HAD) sub-scores 4.Self-rating Depression Scale (SDS) scores 5.Leeds Sleep Evaluation Questionnaire (LSEQ) scores 6.Safety from baseline to Wend ;Timepoint(s) of evaluation of this end point: 1.Hamilton Anxiety (HAM-A) items: from baseline to W12 2.Clinical Global Impression Severity (CGI-S) and Clinical Global Impression Improvement (CGI-I): from baseline to W13 3.Hospital Anxiety Depression (HAD) sub-scores: from baseline to W12 4.Self-rating Depression Scale (SDS) scores: from baseline to W12 5.Leeds Sleep Evaluation Questionnaire (LSEQ) scores: from W2 to W12 6.Safety from baseline to Wend: final visit	—

Measure

Time frame

Secondary end point(s): 1.Hamilton Anxiety (HAM-A) items 2.Clinical Global Impression Severity (CGI-S) and Clinical Global Impression Improvement (CGI-I) 3.Hospital Anxiety Depression (HAD) sub-scores 4.Self-rating Depression Scale (SDS) scores 5.Leeds Sleep Evaluation Questionnaire (LSEQ) scores 6.Safety from baseline to Wend ;Timepoint(s) of evaluation of this end point: 1.Hamilton Anxiety (HAM-A) items: from baseline to W12 2.Clinical Global Impression Severity (CGI-S) and Clinical Global Impression Improvement (CGI-I): from baseline to W13 3.Hospital Anxiety Depression (HAD) sub-scores: from baseline to W12 4.Self-rating Depression Scale (SDS) scores: from baseline to W12 5.Leeds Sleep Evaluation Questionnaire (LSEQ) scores: from W2 to W12 6.Safety from baseline to Wend: final visit

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Countries

Argentina, Czech Republic, Finland, Korea, Republic of, Poland, Russian Federation, Slovakia, Slovenia

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier (IRIS)

clinicaltrials@servier.com+33155 72 43 66

Outcome results

None listed

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