Treatment of severely depressed patients MedDRA version: 9.1 Level: LLT Classification code 10012378 Term: Depression
Conditions
Interventions
Trade Name: Cymbalta
Pharmaceutical Form: Gastro-resistant capsule, hard
CAS Number: 136434-34-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical
Sponsors
BOEHRINGER ING.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female patients of 18 years of age that meet criteria for severe Major Depressive Disorder, without psychotic features according to DSM-IV and confirmed by MINI . -With a total score MADRS 30 and HAMD-6 12 and CGI-Severity 4 at both screening and baseline. -Patients willing and able to comply with the requirement for hospitalization at least up to Visit 4 and with all scheduled visits, tests and procedures required by the protocol. -Informed consent document must be signed at screening visit, in accordance with GCP and local regulatory requirements, prior to any study procedure. 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
Exclusion criteria: -Treatment resistant depression. -Concurrent presence of any Axis I disorder other than anxiety disorders with exception of the Obsessive-Compulsive Disorder OCD or Major Depressive Disorder; any previous diagnosis of a bipolar disorder, schizophrenia or OCD. -Depression with catatonic features according to DSM IV , depression with post-partum onset, or organic mental disorders. -The presence of an Axis II disorder. -MDD with psychotic features requiring neuroleptic treatment and/or interfering with patient s ability to provide informed consent, at investigator s discretion. -DSM-IV-defined-history of substance abuse or dependence within the past year. -Positive urine screen for drug abuse. -Epilepsy or a history of seizure disorder or of a treatment with anticonvulsant medication for epilepsy or seizures. -Patients with acute liver injury or severe cirrhosis. -Known diagnosis of congenital galactosaemia, glucose or galactose malabsorption syndrome, or lactose deficiency. -Patient with a known diagnosis of raised intraocular pressure, or at known risk of acute narrow-angle glaucoma. -Serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require intervention/hospitalization/exclusion of study medication during the course of the study cardiovascular e.g. uncontrolled hypertension , respiratory, haematological, hepatal or gastrointestinal. End stage renal disease estimated creatinine clearance 30 mL/min and undergoing dialysis. -Abnormal TSH concentrations, based on the performing laboratory s reference ranges. Patients must be clinically and chemically euthyroid at the time of randomization. Patients may be taking thyroid replacement therapy provided their dose is stable and their compliance is good for at least three months before the screening visit. -Pregnancy or breast-feeding. -Sexually active woman of childbearing potential not using a medically approved method of birth control for at least one month prior to the screening visit and throughout the study. -Known hypersensitivity to Duloxetine or any of the inactive ingredients. -History of oversensitivity to psychotropic drugs. -Electro-convulsive Therapy ECT or Transcranial Magnetic Stimulation TMS within one year prior to screening visit and during the study. -Initiation or discontinuation of depression-oriented psychotherapeutic treatment within 6 weeks prior to screening visit, or planned use of such treatment at any time during the study. -Treatment with a Monoamine Oxidase Inhibitor MAOI within 14 days prior to baseline visit V2 or the potential need to use an MAOI during the study or within 5 days after discontinuation of duloxetine, or treatment with Fluoxetine within 30 days prior to baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show superiority of Duloxetine 120 mg over Duloxetine 60 mg in patients hospitalized for severe depression after 4 weeks of treatment;Secondary Objective: To evaluate the rescue option in non-responding patients and the safety of Duloxetine;Primary end point(s): Change in the MADRS total score from baseline to week 4 | — |
Countries
France, Italy
Outcome results
None listed