Efficacy and safety of agomelatine for 12 weeks in non-depressed out-patients with Generalised Anxiety Disorder

ISRCTN	ISRCTN03554974
DOI	https://doi.org/10.1186/ISRCTN03554974
Clinical Trials Information System (CTIS)	2009-013789-17
Protocol serial number	CL3-20098-071
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 02/06/2010
Registration date: 05/07/2010
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 Antti Ahokas
Scientific

Mehilainen Clinic
Runeberginkatu 47 A
Helsinki
00260
Finland

Study information

Primary study design	Interventional
Study design	12-week randomised double blind placebo controlled with escitalopram as validator 3-arm parallel group international multicentre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment to 50 mg/day) for 12 weeks in non-depressed out-patients with Generalised Anxiety Disorder
Study objectives	To confirm the superiority of agomelatine compared to placebo in treatment of non-depressed out-patients suffering from Generalised Anxiety Disorder (GAD).
Ethics approval(s)	Committee I. of Ethics in Clinical Trials (Comite I. de Etica para Ensayos en Farmacologia Clinica) of the University of Medicine at Buenos Aires approved on 26/11/2009
Health condition(s) or problem(s) studied	Generalised Anxiety Disorder
Intervention	Agomelatine 25 or 50 mg versus placebo and escitalopram 10 or 20 mg
Intervention type	Other
Primary outcome measure(s)	Hamilton Anxiety (HAM-A) total score, in the W0-W12 period (baseline to 12 weeks)
Key secondary outcome measure(s)	1. Hamilton Anxiety (HAM-A) items from baseline to W12 (week 12) 2. Clinical Global Impression Severity (CGI-S) and Clinical Global Impression Improvement (CGI-I) scores from baseline to W13 3. Hospital Anxiety Depression (HAD) sub-scores from baseline to W12 4. Self-rating Depression Scale (SDS) scores from baseline to W12 5. Leeds Sleep Evaluation Questionnaire (LSEQ) scores from W2 to W12 6. Safety from baseline to Wend (final visit)
Completion date	31/08/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	390
Key inclusion criteria	1. Out-patients of both genders aged between 18 (or legal majority) and 65 years of age (inclusive) 2. Fulfilling American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria for GAD
Key exclusion criteria	1. Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than GAD within 6 months prior to selection 2. Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women 3. Any relevant clinical abnormality detected during physical examinations, ECG or laboratory tests likely to interfere with the study conduct or evaluations
Date of first enrolment	27/04/2010
Date of final enrolment	31/08/2011

Locations

Countries of recruitment

Argentina
Czech Republic
Finland
Korea, South
Poland
Russian Federation
Slovakia

Study participating centre

Mehilainen Clinic

Helsinki
00260
Finland

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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?
Results article	results	01/04/2014		Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.