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 Generalised Anxiety Disorder

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN03554974

Enrollment

390

Registered

2010-07-05

Start date

2010-04-27

Completion date

Unknown

Last updated

2018-05-21

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

Conditions

Generalised Anxiety Disorder Mental and Behavioural Disorders Other anxiety disorders

Interventions

Agomelatine 25 or 50 mg versus placebo and escitalopram 10 or 20 mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Out-patients of both genders aged between 18 (or legal majority) and 65 years of age (inclusive) 2. Fulfilling American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria for GAD

Exclusion criteria

Exclusion criteria: 1. Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than GAD within 6 months prior to selection 2. Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women 3. 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
Hamilton Anxiety (HAM-A) total score, in the W0-W12 period (baseline to 12 weeks)	—

Secondary

Measure	Time frame
1. Hamilton Anxiety (HAM-A) items from baseline to W12 (week 12) 2. Clinical Global Impression Severity (CGI-S) and Clinical Global Impression Improvement (CGI-I) scores 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

1. Hamilton Anxiety (HAM-A) items from baseline to W12 (week 12) 2. Clinical Global Impression Severity (CGI-S) and Clinical Global Impression Improvement (CGI-I) scores 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, South, Poland, Russian Federation, Slovakia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026