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

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder; Mental and Behavioural Disorders; Generalized anxiety disorder

• Registration Number: ISRCTN75061806
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-07
• Study Completion: 2014-07-31
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 510

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures