EUCTR2004-004009-10-DE进行中（未招募）不适用
Efficacy of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally on rest/activity circadian rhythms in outpatients with Major Depressive Disorder. A randomized, double-blind international study with parallel groups versus sertraline (50 mg/day with potential adjustment to 100 mg). Six-week treatment plus optional continuation for 18 weeks.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Selection criteria :
- •Demographic criteria : male or female out-patients, aged of 18 to 60 years (both inclusive),
- •Diagnostic criteria :
- •- Fulfilling DSM-IV-TR criteria for Major Depressive Disorder, single or recurrent episode of moderate or severe intensity:
- •. With or without melancholic features according to DSM-IV-TR criteria,
- •. Without seasonal pattern according to DSM-IV-TR criteria,
- •. Without psychotic features,
- •. Without post partum onset for the current episode,
- •. Without catatonic features,
- •. Current episode > or = 4 weeks,
- •- Hamilton Depression Rating Scale :
- •. HAM-D 17 items total score greater than or equal to 22,
- •. Sum of HAM-D item 5 Insomnia: middle of the night” + item 6 Insomnia: early hours of the morning” greater than or equal to 3,
- •- Requiring an antidepressant treatment,
- •- Hospital Anxiety Depression Scale : HAD completed by the patient to characterize the anxiety condition and to make sure that depression predominates on anxiety, if any.
- •- Barratt Impulsiveness Scale : BIS-11 completed by the patient to measure impulsivenes.
- •- Patient agrees to wear an actimeter and to fill in a sleep-wake diary during the seven continuous weeks, starting at the selection visit.
- •The safety examination of the patients includes the following tests and will check for the absence of any abnormalities likely to interfere with the study conduct or evaluations:
- •- prescription of laboratory tests (biochemistry including T3, T4, TSH and pregnancy test, haematology and benzodiazepines tests). Results must be available for the inclusion visit.
- •- Prescription of a 12-lead ECG. Results and ECG tracing must be available for the inclusion visit.
- •Inclusion criteria :
- •- The investigator will check that the selection criteria are still fulfilled, especially Diagnostic criteria”,
- •- HAM-D 17-items total score still greater than or equal to 22,
- •- HAM-D item 3 (suicide) minor than or equal to 2,
- •- HAM-D decrease (if any) between ASSE and W0 minor than or equal to 20%,
- •- Sum of HAM-D items 5+6 greater than or equal to 3,
- •- Sum of items H1+H2+H5+H6+H7+H8+H10+H13 (core of depression + 2 items on sleep 5 and 6) of HAM-D 17-items greater than or equal to 55% of HAM-D 17-items total score, checked by IVRS,
- •- CGI item 1 Severity of illness” greater than or equal to 4 (moderately to severely ill).
- •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
排除标准
- •Demographic and general non-selection criteria :
- •Women of childbearing potential without effective contraception.
- •Medical and therapeutic non-selection criteria :
- •Psychiatric criteria - Other Depressive Disorders :
- •- All types of depression other than Major Depressive Disorder :
- •. Bipolar Disorder I and II,
- •. Double Depression (Major Depressive Disorder superimposed on Dysthymic Disorder according to DSM-IV-TR),
- •. Chronic Depression (duration of the episode longer than 2 years),
- •. Schizoaffective Disorder Depressive or Bipolar type,
- •. Dysthymic Disorder according to DSM-IV criteria (checked by the M.I.N.I.)
- •- Depression onset within 3 months after a stroke.
- •- Current depressive episode having not responded to 2 different previous antidepressant treatments of at least 4 weeks at an appropriate dose.
- •- Previous non responders to sertraline or hypersensitivity to sertraline.
- •- Previous non responders to agomelatine (for patients having participated in a previous clinical trial).
- •- Marked suicidal intent and/or known suicidal tendencies for the current episode defined as HAM-D item 3 score > 2 and the investigator's opinion based on the patient’s medical history, previous suicide attempts, quality of social and familial support within the last 6 months.
- •- Patient treated with ECT (Electro Convulsive Therapy) within the last 3 months before selection or requiring ECT at present (according to investigator’s clinical judgement).
- •- Insight-oriented (psychoanalysis) and other structured psychotherapy (interpersonal therapy, cognitive behavioural therapy) started within 3 months before inclusion.
- •- Light-therapy started within 2 weeks before inclusion.
- •Psychiatric criteria - Other psychiatric conditions according to DSM-IV:
- •- Anxiety disorders according to DSM-IV criteria (checked by the M.I.N.I.).
- •. Current Panic Disorder,
- •. Obsessive Compulsive Disorder,
- •. Post Traumatic Stress Disorder,
- •. Acute Stress Disorder.
- •- Patients with acute or chronic psychosis.
- •- Patients with antisocial, borderline or histrionic personality disorders according to DSM IV-TR criteria.
- •- Patients with a severe personality disorder other than antisocial, borderline or histrionic personality disorders and prone to interfere with the evaluation of the study according to the investigator’s judgement.
- •- Delirium or dementia according to DSM-IV-TR.
- •Sleep Disorders :
- •- Known Obstructive Sleep Apnea Syndrome previously diagnosed and not treated.
- •- Restless legs syndrome.
- •- Shift workers.
- •- Transmeridian flight (greater than or equal to 3 time zones) in the past 10 days before inclusion or planned in the first 6 weeks of the study.
- •Non-inclusion criteria :
- •- Any clinically relevant abnormality detected during the physical examination or the laboratory tests, and likely to interfere with the conduct of the study or with the evaluations, especially:
- •. Hepatic failure : gGT or transaminases > than 3 times the upper limit,
- •. Renal failure : creatinin > 150 mmol/l,
- •. Positive beta hCG for women,
- •. Positive drug screening for benzodiazepines.
- •- Clinically relevant ECG abnormality, according to the investigator’s opinion.
- •- Treatment with a forbidden drug present at inclusion.
- •- IVRS refusal, if inclusion criteria not respected.
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