Long-term efficacy and safety of agomelatine in non-depressed out-patients with generalized anxiety disorder. A 26-week randomised double-blind placebo-controlled parallel group study following an open-label period of 16 weeks with agomelatine (25 mg/day with the possibility for blinded dose-adjustment to 50 mg/day)

ISRCTN	ISRCTN38094599
DOI	https://doi.org/10.1186/ISRCTN38094599
EudraCT/CTIS number	2006-005674-47
Secondary identifying numbers	CL3-20098-050

Submission date: 24/09/2007
Registration date: 26/03/2008
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

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

Contact information

Prof Istvan Bitter
Scientific

Department of Psychiatry and Psychotherapy
Semmelweis University
Balassa u.6.
Budapest
1083
Hungary

Study information

Study design	Randomised double-blind parallel-group placebo-controlled multi-centre phase III study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Long-term efficacy and safety of agomelatine in non-depressed out-patients with Generalized Anxiety Disorder.A 26-week randomised double-blind placebo-controlled parallel group study following an open-label period of 16 weeks with agomelatine (25mg/day with the possibility for blinded dose-adjustment to 50mg/day).
Study hypothesis	To assess the efficacy of agomelatine in the prevention of relapse in non-depressed out-patients with Generalized Anxiety Disorder (GAD) after an initial response to agomelatine.
Ethics approval(s)	First ethics committee approval in Estonia (Tallin Medical Research Ethics Committee) on 16/08/2007 (ref: 1121)
Condition	Generalized anxiety disorder
Intervention	Agomelatine versus placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Agomelatine
Primary outcome measure	Time to relapse
Secondary outcome measures	1. Evaluation of anxiety (Hamilton rating scale for anxiety [HAM-A]) 2. Safety
Overall study start date	15/10/2007
Overall study end date	15/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	370
Participant inclusion criteria	1. Aged over 18 years 2. Out-patients of both genders 3. Fulfilling the Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV) criteria for GAD
Participant exclusion criteria	1. Women of childbearing potential without effective contraception 2. Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than GAD 3. Any clinically relevant abnormality detected during the physical examination, ECG or laboratory tests likely to interfere with the study conduct or evaluations
Recruitment start date	15/10/2007
Recruitment end date	15/03/2010

Locations

Countries of recruitment

Canada
Denmark
Estonia
Finland
Hungary
Sweden

Study participating centre

Department of Psychiatry and Psychotherapy

Budapest
1083
Hungary

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
Results article	results	01/07/2012		Yes	No

Editorial Notes

18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement updated.
25/01/2018: Publication plan and IPD sharing statement added.
18/12/2017: results summary added.