Critical appraisal and update on the clinical utility of agomelatine, a melatonergic agonist, for the treatment of major depressive disease in adults

Figures & data

Table 1 Summary of randomized controlled clinical efficacy studies of agomelatine

Study (Reference)	Design	Comparison	Study outcome
Loo et al^Citation58	Efficacy and safety	AGO 1 mg	AGO 1 mg = PBO
	8 weeks	AGO 5 mg	AGO 5 mg = PBO
	711 subjects	AGO 25 mg	AGO 25 mg >> PBO
		PBO	PAr >> PBO
		PAR 20 mg
Kennedy and emsley^Citation59	Efficacy and safety	AGO 25–50 mg	AGO >> PBO
	6 weeks	PBO
	212 subjects
Olie and Kasper^Citation60	Efficacy and safety	AGO 25–50 mg	AGO >> PBO
	6 weeks	PBO
	238 subjects
CL3-022^Citation25	Efficacy and safety	AGO 25 mg	AGO = PBO
	6 weeks	PBO	FLX >> PBO
	419 subjects	FLX 20 mg
CL3-023^Citation25	Efficacy and safety	AGO 25 mg	AGO = PBO
	6 weeks	PBO	PAR = PBO
	418 subjects	PAR 20 mg
CL3-024^Citation25	Efficacy and safety	AGO 25 mg	AGO = PBO
	6 weeks	AGO 50 mg	FLX = PBO
	607 subjects	PBO
		FLX 20 mg
CL3-026^Citation25	Efficacy and safety in elderly	AGO 25 mg	AGO = PBO
	6 weeks	PBO
	218 subjects
Goodwin et al^Citation61	Relapse prevention	AGO 25–50 mg	AGO >> PBO
	34 weeks	PBO
	339 subjects
CL3-021^Citation25	Relapse prevention	AGO 25 mg	AGO = PBO
	34 weeks	PBO
	367 subjects

Notes: >> denotes significantly better than; = denotes no significant difference.

Abbreviations: AGO, agomelatine; PBO, placebo; PAR, paroxetine; FLX, fluoxetine.

LooHHaleAD’HaenenHDetermination of the dose of agomelatine, a melatoninergic agonist and selective 5-HT2C antagonist, in the treatment of major depressive disorder: A placebo-controlled dose range studyInt Clin Psychopharmacol20021723924712177586

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KennedySHEmsleyRPlacebo-controlled trial of agomelatine in the treatment of major depressive disorderEur Neuropsychopharmacol20061629310016249073

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OlieJPKasperSEfficacy of agomelatine, a MT1/MT2 receptor agonist with 5-HT2C antagonistic properties, in major depressive disorderInt J Neuropsychopharmacol20071066167317477888

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GoodwinGMEmsleyRRembrySRouillonFfor the Agomelatine Study GroupAgomelatine prevents relapse in patients with major depressive disorder without evidence of a discontinuation syndrome: A 24-week randomized double-blind placebo-controlled trialJ Clin PsychiatryIn Press.

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