EUCTR2005-002388-95-HUActive, not recruitingNot Applicable
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.
Institut de Recherches Internationales Servier0 sites400 target enrollmentStarted: August 18, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
Similar Trials
Completed
Phase 3
Efficacy of agomelatine given orally on improvement of subjective sleep in patients with major depressive disorder: a randomised, double-blind, flexible-dose international multicentre study with parallel groups versus Selective Serotonin Reuptake Inhibitor (SSRI) twelve week treatment plus double-blind extension for 12 weeksMental and Behavioural DisordersDepressive episodeMajor Depressive DisorderISRCTN55250367Institut de Recherches Internationales Servier (France)324
Active, not recruiting
Phase 1
Efficacy of agomelatine (25 to 50 mg/day) given orally on improvement of subjective sleep in patients with Major Depressive Disorder. A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus escitalopram (10 to 20mg/day). Twelve-week treatment plus double-blind extension for 12 weeks.MedDRA version: 9.1 Level: LLT Classification code 10057840 Term: Major depressionMajor Depressive DisorderEUCTR2006-006540-54-GBServier Research and Development Limited300
Active, not recruiting
Not Applicable
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.MedDRA version: 3.3Level: P.T.Classification code 10025453Major Depressive DisorderEUCTR2005-002388-95-BEInstitut de Recherches Internationales Servier400
Active, not recruiting
Not Applicable
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.Major Depressive DisorderEUCTR2005-002388-95-PTInstitut de Recherches Internationales Servier400
Active, not recruiting
Phase 1
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.MedDRA version: 3.3Level: P.T.Classification code 10025453Major Depressive DisorderEUCTR2005-002388-95-ESaboratorios Servier S.L. (For Spain only)400