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Clinical Trial Results:
Efficacy and safety of 2 doses of agomelatine (10 mg/day or 25 mg/day) versus placebo given orally for 12 weeks in non depressed out-patients with Generalized Anxiety Disorder. A 12-week randomised, double-blind, placebo-controlled, 3-arm parallel groups, international multicenter study.

Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.

Summary
EudraCT number	2012-001666-15
Trial protocol	FI SK PL
Global end of trial date	21 Jan 2015

Results information
Results version number	v1(current)
This version publication date	27 Apr 2016
First version publication date	27 Apr 2016
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CL3-20098-087

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Institut de Recherches Internationales Servier

Sponsor organisation address

50 rue Carnot, Suresnes Cedex, France, 92284

Public contact

Clinical Studies Department, Institut de Recherches Internationales Servier, +33 1 55 72 43 66, clinicaltrials@servier.com

Scientific contact

Clinical Studies Department, Institut de Recherches Internationales Servier, +33 1 55 72 43 66, clinicaltrials@servier.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

21 Jan 2015

Is this the analysis of the primary completion data?

Yes

Primary completion date

21 Jan 2015

Global end of trial reached?

Yes

Global end of trial date

21 Jan 2015

Was the trial ended prematurely?

Main objective of the trial

To demonstrate the short-term efficacy of at least one of the 2 dose regimens of agomelatine (versus placebo) using Hamilton Anxiety (HAM-A ) scale after a 12-week treatment period in non-depressed out-patients suffering from Generalized Anxiety Disorder (GAD).

Protection of trial subjects

The study was conducted in accordance with Good Clinical Practice standards, ethical principles stated in the Declaration of Helsinki and applicable regulatory requirements. After the subject has ended his/her participation in the trial, the investigator provided appropriate medication and/or arranged access to appropriate care for the patient. Criteria for mandatory discontinuation of treatment were: - Absence of written consent or consent withdrawal by the patient. - Suicidal risk, according to investigator's judgment and or with a suicidal ideation of 4 or 5 on Columbia Suicide Severity Rating Scale (C-SSRS). - Any suicide attempt during the study whatever its severity (could be checked with C-SSRS suicidal behavior part). - Pregnancy. - ALT or AST > 8 ULN , or ALT or AST > 5 ULN and sustained after two weeks of close monitoring. - ALT or AST > 3 ULN and total bilirubin > 2 ULN. - ALT or AST > 3 ULN with clinical signs of hepatitis. - Symptoms or signs of potential liver injury: such as dark urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, sustained new-onset and unexplained fatigue. Other criteria for premature discontinuation of treatment were: - Any event or circumstance related or unrelated to treatment justifying the discontinuation of the treatment in the investigator's opinion. - Treatment failure, i.e. lack of efficacy which in the opinion of the investigator required the patients to be withdrawn. All withdrawals for worsening of GAD were to be considered as lack of efficacy. - Adverse event - Any protocol deviation which jeopardized the patient’s safety. - Lost to follow-up.

Background therapy

Evidence for comparator

Placebo

Actual start date of recruitment

19 Aug 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country