Efficacy and safety of agomelatine (25-50 mg/day) for 12 weeks in patients with Generalized Anxiety Disorder

Efficacy and safety of agomelatine (25-50 mg/day) for 12 weeks in patients with Generalized Anxiety Disorder: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75061806

Enrollment

510

Registered

2012-08-07

Start date

2012-11-01

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

Generalized Anxiety Disorder Mental and Behavioural Disorders Generalized anxiety disorder

Interventions

Therapeutic oral doses of agomelatine (25-50mg/day p.o.) and of Serotonin?norepinephrine reuptake inhibitors (SNRI), venlafaxine (p.o.), a 12 weeks study.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Asian patients aged 18 years 2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder diagnosis confirmed by the M.I.N.I. questionnaire and requiring a psychotropic treatment. 3. Hamilton Anxiety Scale (HAM-A) total score >22

Exclusion criteria

Exclusion criteria: 1. All types of current anxiety disorders (within 6 months prior to the selection visit) other than generalized anxiety disorder (GAD) 2. Current diagnosis of any other psychiatric disorders than GAD or severe or uncontrolled organic disease 3. Any clinically relevant abnormality detected during the physical examination, ECG, liver B ultrasound exams or laboratory tests likely to interfere with the study conduct or evaluations 4. Pregnancy or breastfeeding women

Design outcomes

Primary

Measure	Time frame
HAM-A total score expressed mainly in terms of change from baseline to last post-baseline value over the 12-week period.	—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

China, Hong Kong, Malaysia, Singapore, Taiwan, Thailand

Outcome results

None listed

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