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ISRCTN
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ISRCTN38094599
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ClinicalTrials.gov identifier
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Public title
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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 (25 mg/day with the possibility for blinded dose-adjustment to 50 mg/day)
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Scientific title
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Acronym
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N/A
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Serial number at source
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CL3-20098-050
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Study hypothesis
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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.
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Ethics approval
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First ethics committee approval in Estonia (Tallin Medical Research Ethics Committee) on 16 August 2007 (ref: 1121)
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Study design
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Randomised, double-blind, parallel group, placebo-controlled, multi-centre, phase III study.
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Countries of recruitment
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Canada, Europe.
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Disease/condition/study domain
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Generalized anxiety disorder
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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15/10/2007
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Anticipated end date
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15/03/2010
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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370
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Interventions
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Agomelatine versus placebo
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Primary outcome measure(s)
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Time to relapse
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Secondary outcome measure(s)
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1. Evaluation of anxiety (Hamilton rating scale for anxiety [HAM-A])
2. Safety
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Sources of funding
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Institut de Recherches Internationales Servier (France)
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Trial website
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Publications
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Contact name
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Prof
Istvan
Bitter
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Address
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Department of Psychiatry and Psychotherapy
Semmelweis University
Balassa u.6.
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City/town
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Budapest
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Zip/Postcode
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1083
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Country
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Hungary
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Sponsor
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Institut de Recherches Internationales Servier (France)
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Address
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6, Place des Pléiades
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City/town
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Courbevoie
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Zip/Postcode
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92415
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Country
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France
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Date applied
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24/09/2007
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Last edited
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26/03/2008
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Date ISRCTN assigned
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26/03/2008
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