Condition category
Mental and Behavioural Disorders
Date applied
02/06/2010
Date assigned
05/07/2010
Last edited
27/06/2014
Prospective/Retrospective
Retrospectively 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 Antti Ahokas

ORCID ID

Contact details

Mehilainen Clinic
Runeberginkatu 47 A
Helsinki
00260
Finland

Additional identifiers

EudraCT number

2009-013789-17

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-071

Study information

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

Acronym

Study hypothesis

To confirm the superiority of agomelatine compared to placebo in treatment of non-depressed out-patients suffering from Generalised Anxiety Disorder (GAD).

Ethics approval

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

Study design

12-week randomised double blind placebo controlled with escitalopram as validator 3-arm parallel group international multicentre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Generalised Anxiety Disorder

Intervention

Agomelatine 25 or 50 mg versus placebo and escitalopram 10 or 20 mg

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Hamilton Anxiety (HAM-A) total score, in the W0-W12 period (baseline to 12 weeks)

Secondary outcome measures

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)

Overall trial start date

27/04/2010

Overall trial end date

31/08/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

390

Participant 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

Recruitment start date

27/04/2010

Recruitment end date

31/08/2011

Locations

Countries of recruitment

Argentina, Czech Republic, Finland, Korea, South, Poland, Russian Federation, Slovakia

Trial participating centre

Mehilainen Clinic
Helsinki
00260
Finland

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24569045

Publication citations

  1. Results

    Stein DJ, Ahokas A, Márquez MS, Höschl C, Oh KS, Jarema M, Avedisova AS, Albarran C, Olivier V, Agomelatine in generalized anxiety disorder: an active comparator and placebo-controlled study., J Clin Psychiatry, 2014, 75, 4, 362-368, doi: 10.4088/JCP.13m08433.

Additional files

Editorial Notes