Condition category
Mental and Behavioural Disorders
Date applied
24/09/2007
Date assigned
26/03/2008
Last edited
14/07/2014
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 Istvan Bitter

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2006-005674-47

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-050

Study information

Scientific title

Acronym

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

First ethics committee approval in Estonia (Tallin Medical Research Ethics Committee) on 16/08/2007 (ref: 1121)

Study design

Randomised double-blind parallel-group placebo-controlled multi-centre phase III study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

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

Agomelatine versus placebo

Intervention type

Drug

Phase

Phase III

Drug names

Agomelatine

Primary outcome measures

Time to relapse

Secondary outcome measures

1. Evaluation of anxiety (Hamilton rating scale for anxiety [HAM-A])
2. Safety

Overall trial start date

15/10/2007

Overall trial end date

15/03/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

370

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

Trial participating centre

Department of Psychiatry and Psychotherapy
Budapest
1083
Hungary

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22901350

Publication citations

  1. Results

    Stein DJ, Ahokas A, Albarran C, Olivier V, Allgulander C, Agomelatine prevents relapse in generalized anxiety disorder: a 6-month randomized, double-blind, placebo-controlled discontinuation study., J Clin Psychiatry, 2012, 73, 7, 1002-1008, doi: 10.4088/JCP.11m07493.

Additional files

Editorial Notes