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

ISRCTN	ISRCTN75061806
DOI	https://doi.org/10.1186/ISRCTN75061806
Secondary identifying numbers	CL3-20098-078

Submission date: 04/07/2012
Registration date: 07/08/2012
Last edited: 18/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration and not expected to be available in the future

Contact information

Prof Jing Ping Zhao
Scientific

Mental Health Institute
The Second Xiangya Hospital of Central South University
No. 139, Renmin Middle Road
Changsha, Hunan, P.R.
410011
China

Phone	+86 0731 5360921
Email	clinicaltrials@servier.com

Study information

Study design	12-week randomised double-blind two-arm parallel groups international multicenter study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Efficacy and safety of agomelatine (25-50 mg/day) for 12 weeks in patients with Generalized Anxiety Disorder: a randomised controlled trial
Study objectives	To assess the efficacy of agomelatine compared to venlafaxine after treatment in non-depressed outpatients suffering from Generalized Anxiety Disorder (GAD).
Ethics approval(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	Generalized Anxiety Disorder
Intervention	Therapeutic oral doses of agomelatine (25-50mg/day p.o.) and of Serotoninnorepinephrine reuptake inhibitors (SNRI), venlafaxine (p.o.), a 12 weeks study.
Intervention type	Other
Primary outcome measure	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	No secondary outcome measures
Overall study start date	01/11/2012
Completion date	31/07/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	510
Key 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
Key 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
Date of first enrolment	01/11/2012
Date of final enrolment	31/07/2014

Locations

Countries of recruitment

China
Hong Kong
Malaysia
Singapore
Taiwan
Thailand

Study participating centre

Mental Health Institute

Changsha, Hunan, P.R.
410011
China

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Summary results are published in https://clinicaltrials.servier.com. For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No

Editorial Notes

18/04/2018: Internal review.
28/03/2018: Publication plan and IPD sharing statement updated.
25/01/2018: Publication plan and IPD sharing statement added.
19/12/2017: results summary added.
09/05/2017: contact email address added.