A study to determine the maintenance of efficacy of agomelatine (25 mg to 50 mg) to prevent relapse in out-patients with Major Depressive Disorder. A 8 to 10 weeks open period treatment with agomelatine (25 mg to 50 mg) followed by 24 weeks randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period.

Institut de Recherches Internationales Servier0 个研究点目标入组 500 人开始时间: 2005年2月23日最近更新: 2019年11月25日

适应症

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•Selection criteria
•- Out-patients
•- Fulfilling DSM IV-TR criteria for Major Depressive Disorder of moderate or severe intensity:
•- Recurrent episode and at the beginning of the index episode patients must have been free of depressive symptoms of their previous episode for at least 6 months,
•- With or without melancholic features according DSM IV-TR criteria
•- Without seasonal pattern according DSM IV-TR criteria
•- Without psychotic features,
•- Without post partum onset for the current episode,
•- Current episode >or= 8 weeks
•Inclusion Criteria For The Open Period:
•- HAM-D 17-item score still >or= 22 and decrease (if any) between ASSE and W0 = 20%.
•- Sum of items H1+H2+H5+H6+H7+H8+H10+H13 of HAM-D 17-item >or= 55% HAM-D 17-item total score.
•- CGI item 1: Severity of illness >or= 4 (moderately ill to severely ill).
•- Hospital Anxiety Depression Scale: HAD completed and HAD-D sub-score >or=11,
•Randomisation criteria For The Double Blind Period:
•- Patients having completed the 8 to 10 weeks of open” treatment.
•- Patients improved by agomelatine 25 mg or 50 mg after 8 to 10 weeks of open” treatment.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Non selection Criteria
•- All types of depression other than Major Depressive Disorder
•- Severe or uncontrolled organic disease, likely to interfere with the conduct of the study (e.g. neoplastic, cardiovascular, pulmonary and digestive disorders, unstabilized diabetes of type I or II, untreated or uncontrolled clinically significant arterial hypertension). Patients whose state is stabilized under treatment may be included.
•Non Inclusion Criteria For The Open Period:
•- Any non-selection criteria which could have appeared after the selection visit.
•- Any clinically relevant abnormality detected during the physical examination, ECG or laboratory test likely to interfere with the study conduct or evaluation.
•- Positive pregnancy test.
•- gGT or transaminases values > 3 times the upper limit or blood creatinin > 150 mmol/l.
•- IVRS refusal.
•Non randomisation Criteria:
•- IVRS refusal.

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