Efficacy of agomelatine (25 to 50 mg/day) given orally on quality of remission in elderly depressed patients, after a 12-week treatment period.A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus paroxetine (20 to 30 mg/day).Twelve-week treatment plus optional continuation for 12 weeks.
- Conditions
- Major Depressive DisorderMedDRA version: 3.3Level: P.T.Classification code 10025453
- Registration Number
- EUCTR2005-002388-95-ES
- Lead Sponsor
- aboratorios Servier S.L. (For Spain only)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Selection criteria:
Demographic characteristics:
Outpatients of both genders, aged at least 60, fulfilling DSM-IV TR criteria for Major Depressive Disorder, recurrent episode with a score HAM-D-17 > or = 22.
Diagnosis criteria :
The clinical examination performed at selection visit will check the following patients characteristics :
-Fulfilling DSM-IV TR criteria for Major Depressive Disorder of moderate or severe intensity: recurrent episode (at least one previous episode)
-Diagnosis documented using the brief structured interview M.I.N.I..
-Hamilton Depression Rating Scale : HAM-D 17 items total score > or = 22.
-Requiring an antidepressant treatment.
-Able to go untreated until the inclusion visit.
The investigator will check that the selection criteria are still fulfilled and :
-Hamilton Depression Rating Scale: HAM-D 17 items total score still > or = 22 and HAMD decrease between ASSE and W0 < or = 20%.
-Sum of scores at items 1+2+5+6+7+8+10+13 of HAMD-17 > or = 55% HAM-D total score.
-Clinical Global Impression: CGI severity of illness > or = 4 (moderately ill to severely ill).
-Results of laboratory tests and ECG must be available and free of any clinically significant abnormalities likely to interfere with the study conduct or evaluations.
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) yes
F.1.3.1 Number of subjects for this age range
Non-selection criteria:
General criteria:
-Patients living in an aged care facility or in a nursing home or in long term care settings, i.e. people needing assistance in their daily life
-Patients likely to become institutionalised during the study
Medical and therapeutic criteria
Psychiatric criteria
Other Depressive Disorders :
-All types of depression other than Major Depressive Disorder
-Depression onset within the 3 months after a stroke,
-Resistant depression (for the current episode or for the previous ones) : patients who have not responded to 2 different previous antidepressant treatments of at least 4 weeks at an appropriate dose.
-Marked suicidal intent and/or known suicidal tendencies for the current episode defined as a score > or = 3 at the item of the HAM-D and the investigator’s opinion based on the patient’s medical history, previous suicide attempts, quality of social and familial support.
-Patients treated with ECT (Electro Convulsive Therapy) within the last 3 months before inclusion or requiring ECT at present (according to investigator’s clinical judgement).
-Insight-oriented and structured psychotherapy started within the 3 months before inclusion.
-Light-therapy started within 2 weeks before inclusion.
-Patients having not responded to agomelatine in a previous trial.
-Patients previously not responders to paroxetine.
-Other Psychiatric Disorders according to DSM-IV TR
Sleep Disorders :
-Known Obstructive Sleep Apnea Syndrome previously diagnosed and not treated.
-Restless legs syndrome.
-Shift workers.
-Transmeridian flight (> or = 3 time zones) in the past 10 days before the inclusion or planned in the first 12 weeks of the study).
Miscellaneous conditions :
-Current diagnosis of neurological disorders : e.g. stroke, seizures, epilepsy, migraine…
-Cognitive dysfunction : Mini Mental State Examination score (MMSE)<25
-Alcohol or drug abuse or dependence within the past 12 months (excluding nicotine), as defined in DSM-IV TR.
-Delirium or dementia
-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.
-Hypothyroidism or Hyperthyroidism, except if the treatment has been stabilised for at least 3 months (Thyroid hormones levels will be checked before inclusion).
-Present diagnosis of hepatic disorder or renal failure or hyponatremia.
-Hemostasis abnormality.
-Inability to tolerate lactose.
-Hypersensitivity to SSRIs.
Non-inclusion criteria
-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.
-gGT or transaminases values > 3 times the upper reference value or creatinin clearance < 50 ml/min (calculated with Cockroft’s formula) or sodium value below the lower reference value.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method