Major depressive disorder in elderly patients MedDRA version: 9.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient is able to read and understand the Subject Information Sheet. 2) The patient has signed the Informed Consent Form. No study-related procedures may be performed before the patient has signed the form. 3) The patient is man or woman aged 65 years or over. 4) The patient suffers from a recurrent Major Depressive Episode, diagnosed according to DSM-IV-TR criteria (classification code 296.3x), as primary diagnosis. 5) The patient had at least one previous MDE before the age of 60 years. 6) The patient has a reported duration of the current MDE of at least 4 weeks prior to Screening Visit. 8) The patient has a Montgomery Åsberg Depression Rating Scale (MADRS) total score greater then/ egual to 26. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: A patient who meets one or more of the following criteria, both at the Screening Visit and at the Baseline Visit, is not eligible for inclusion in this study: 1) The patient has a Mini Mental State Exam (MMSE) score <24 (Screening Visit only) 2) The patient has 1 or more of the following: - Any current anxiety disorders as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview [MINI]). - Current or past history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR. - Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. - Presence or history of a clinically significant neurological disorder (including epilepsy). - Neurodegenerative disorder (Alzheimer disease, Parkinson’s disease, multiple sclerosis, Huntington disease, etc.). - Any Axis II disorder that might compromise the study. 3) The patient has a significant risk of suicide according to the investigator’s opinion or has a score =5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months. 4) The patient has received electroconvulsive therapy within the 6 months prior to Screening 5) The patient is currently receiving formal cognitive or behavioural therapy, systemic psychotherapy, or plans to initiate such therapy during study. 6) The current depressive symptoms of the patient are considered by the investigator to have been resistant to two adequate antidepressant treatments of at least 6 weeks duration each at the recommended dose. 7) The patient has a history of lack of response to previous adequate treatment with duloxetine (including current episode). 8) The patient has increased intra-ocular pressure or is at risk of acute narrow angle glaucoma. 9) The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to duloxetine. 10) The patient used/uses disallowed recent or concomitant medication (specified in Appendix II in the protocol) or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study. 11) The patient has a chronic liver disease. 12) The patient has a clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance. 13) The patient had a myocardial infarction within the previous 6 months. 14) The patient has clinically significant abnormal vital signs as determined by the investigator. 15) The patient has one or more laboratory values outside the normal range, based on the blood samples taken at the Screening Visit, that are considered by the investigator to be clinically significant. 16) The patient has TSH value outside the normal range at Screening Visit. 17) The patient has a clinically significant abnormal ECG at Screening Visit. 18) The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy. 19) The patient, in the opinion of the investigator, is unlikely to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to assess the efficacy of Lu AA21004 (5mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.;Secondary Objective: 1) Evaluate safety and tolerability of Lu AA21004 (5mg daily) versus placebo in elderly patients 2) Evaluate the efficacy of Lu AA21004 (5mg daily) versus placebo in elderly patients during the 8-week double-blind treatment 3) Evaluate the proportion of elderly patients who respond to Lu AA21004 treatment versus placebo during the 8-week treatment period (response defined as at least 50% reduction on HAM-D24 total score) 4) Evaluate the proportion of elderly patients who are in remission after 8 weeks of treatment with Lu AA21004 versus placebo (remission defined as a MADRS total score £10) 5) Evaluate the effect of Lu AA21004 on Health Related Quality of Life, and health care utilisation in elderly patients 6) Evaluate the efficacy and safety of duloxetine versus placebo on the same parameters as mentioned for the Lu AA21004 7) Evaluate the population pharmacokinetics of Lu AA21004 and its metabolites Lu AA34443 and Lu AA39835 ;Primary end point(s): The primary endpoint of interest is HAM-D24 total score at Week 8 | — |
Countries
Estonia, Finland, France, Germany, Sweden
Outcome results
None listed