Condition category
Mental and Behavioural Disorders
Date applied
04/07/2012
Date assigned
07/08/2012
Last edited
01/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jing Ping Zhao

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-078

Study information

Scientific title

Acronym

Study hypothesis

To assess the efficacy of agomelatine compared to venlafaxine after treatment in non-depressed outpatients suffering from Generalized Anxiety Disorder (GAD).

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

12-week randomised double-blind two-arm parallel groups international multicenter study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Generalized Anxiety Disorder

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2012

Overall trial end date

31/07/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

510

Participant 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

Recruitment start date

01/11/2012

Recruitment end date

31/07/2014

Locations

Countries of recruitment

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

Trial participating centre

Mental Health Institute
Changsha, Hunan, P.R.
410011
China

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes