Additional identifiers
EudraCT/CTIS number
2006-005674-47
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL3-20098-050
Study information
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).
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(s)
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
Study setting(s)
Not specified
Study 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
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
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
Study 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
ROR
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
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.
Intention to publish date
Individual participant data (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.
IPD sharing plan summary
Available on request
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 |