ChiCTR‐TRC‐11001668.

Trial name or title	ChiCTR‐TRC‐11001668
Methods	Eight‐week, randomised, double‐blind, multicentre study with parallel groups
Participants	Outpatients suffering from moderate to severe Major Depressive Disorder, according DSM‐IV‐TR criteria Age range: 18 to 65 years Exclusion criteria: all types of depression other than major depressive disorder and all other psychiatric disorders. Pregnancy, breastfeeding or possibility of becoming pregnant during the study without an effective contraception.
Interventions	Agomelatine: 314 participants Fluoxetine: 314 participants Agomelatine dosage range: 25‐50 mg Fluoxetine dosage range: 20‐40 mg
Outcomes	Change from baseline to end‐point on Depression‐Hamilton Depression Rating Scale‐17 items (HDRS‐17), Clinical Global (CGI) Improvement, Leeds Sleep Evaluation Questionnaire (LSEQ) and Hamilton Anxiety Rating Scale (HAM‐A)
Starting date	August 2006
Contact information	Shu Liang, Prof, +86 10 65610341‐308,  shu‐liang@126.com
Notes	Funding: by industry