|
ISRCTN
|
ISRCTN03554974
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Efficacy and safety of agomelatine for 12 weeks in non-depressed out-patients with Generalised Anxiety Disorder
|
|
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
|
N/A
|
|
Serial number at source
|
CL3-20098-071
|
|
Study hypothesis
|
To confirm the superiority of agomelatine compared to placebo in treatment of non-depressed out-patients suffering from Generalised Anxiety Disorder (GAD).
|
|
Lay summary
|
Not provided at time of registration
|
|
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 the 26th of November 2009
|
|
Study design
|
12-week randomised double blind placebo controlled with escitalopram as validator 3-arm parallel group international multicentre study
|
|
Countries of recruitment
|
Argentina, Czech Republic, Finland, Korea, South, Poland, Russian Federation, Slovakia
|
|
Disease/condition/study domain
|
Generalised Anxiety Disorder
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
27/04/2010
|
|
Anticipated end date
|
31/08/2011
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
390
|
|
Interventions
|
Agomelatine 25 or 50 mg versus placebo and escitalopram 10 or 20 mg
|
|
Primary outcome measure(s)
|
Hamilton Anxiety (HAM-A) total score, in the W0-W12 period (baseline to 12 weeks)
|
|
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)
|
|
Sources of funding
|
Institut de Recherches Internationales Servier (France)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Antti
Ahokas
|
|
Address
|
Mehilainen Clinic
Runeberginkatu 47 A
|
|
City/town
|
Helsinki
|
|
Zip/Postcode
|
00260
|
|
Country
|
Finland
|
|
Sponsor
|
Institut de Recherches Internationales Servier (France)
|
|
Address
|
6, place des Pléiades
|
|
City/town
|
Courbevoie
|
|
Zip/Postcode
|
92415
|
|
Country
|
France
|
|
Date applied
|
02/06/2010
|
|
Last edited
|
30/08/2011
|
|
Date ISRCTN assigned
|
05/07/2010
|
