Major Depressive Disorder MedDRA version: 12.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS MedDRA version: 12.1 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient is able to read and understand the Informed Consent Form. 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 has recurrent Major Depressive Disorder (MDD) as the primary diagnosis according to DSM-IV-TR™ criteria (classification code 296.3x). The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI). 4. The patient has a MADRS total score >26. 5. The patient has a CGI-S score >4. 6. The reported duration of the current MDE is >3 months. 7. The patient is a man or woman, aged >18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The patient: 1. has previously participated in this study. 2. is a member of the site personnel or their immediate families. 3. is pregnant or breast-feeding. 4. has a history of severe drug allergy or hypersensitivity, or knownhypersensitivity to duloxetine. 5. The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each. 6. has a history of lack of response to previous adequate treatment with duloxetine (including current episode). 7. has hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency. 8. has any current anxiety psychiatric disorder (DSM-IV-TR™ criteria), as assessed using the Mini International Neuropsychiatric Interview (MINI). 9. has a current diagnosis or 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 (DSM-IV-TR™ criteria). 10. has a current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) (DSM-IV-TR™ criteria). 11. has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance. 12. has a history of moderate or severe head trauma or other neurological disorders or systemic medical diseases that are likely to affect central nervous system functioning. 13. has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin that has not been in remission for at least 5 years prior to the first dose of IMP. 14. has a clinically significant unstable illness, for example: - neurological/neurodegenerative disorder - cardiovascular disease - seizure disorder or encephalopathy - congestive heart failure - cardiac hypertrophy - arrhythmia - bradycardia (pulse 1.5 times the upper limit of the reference range - a serum total bilirubin value >1.5 times the upper limit of the reference range - a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 times the upper limit of the reference range - a plasma prothrombin tim
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of two fixed doses of Lu AA21004 (15 or 20 mg/day) versus placebo as assessed by the change from baseline in MADRS total score after 8 weeks of treatment in adult patients with moderate to severe MDD.;Secondary Objective: Key secondary objectives to compare the effect of Lu AA21004 to that of placebo at Week 8 on: - patients who respond (response defined as a =50% decrease in the MADRS total score from baseline) - global improvement as assessed by CGI-I - depressive symptoms in patients with a high baseline level of anxiety (defined by HAM-A), as assessed by MADRS total score - patients who are in remission (remission defined as a MADRS total score =10) - disability as assessed by SDS total score Safety objectives to evaluate the: - effect of Lu AA21004 on sexual function as assessed by ASEX versus placebo - safety and tolerability of Lu AA21004 (15 or 20 mg/day) versus placebo during treatment - potential discontinuation symptoms after abrupt discontinuation of treatment with Lu AA21004 Additional objectives are described in the protocol. ;Primary end point(s): The primary endpoint is the change from baseline in MADRS total score after 8 weeks of treatment. | — |
Countries
Estonia, Finland, Germany, Latvia, Lithuania, Sweden
Outcome results
None listed