Major depressive disorder
Conditions
Interventions
investigational material(s)
Generic name etc : LuAA21004
INN of investigational material :
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for Investigational material :
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The subject suffers from Major Depressive Disorder (MDD) as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.2x and 296.3x). 2.The reported duration of the current major depressive episode is at least 3 months at the Screening Visit. 3.The subject has a MADRS total score >= 26 at the Screening and Baseline Visits. 4.The subject has a CGI-S score >= 4 at the Screening and Baseline Visits
Exclusion criteria
Exclusion criteria: 1.The subject has one or more of the following conditions: -Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR. A subject who exhibits symptoms of anxiety is eligible unless the subject fulfills the diagnostic criteria for a current anxiety disorder per DSM-IV-TR. -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 as defined in the DSM-IV-TR. -Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR. -Presence or history of a clinically significant neurological disorder (including epilepsy). -Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, etc.). -Any DSM-IV-TR axis 2 disorder that might compromise the study. 2.The current depressive symptoms of the subject are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each. 3.The subject is at significant risk of suicide or has a score >= 5 on Item 10 (suicidal thoughts) of the MADRS at the Screening and Baseline Visit, or has attempted suicide within 6 months prior to the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Baseline and Week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| MADRS Response at Week 8, with Response Defined as a >= 50% Decrease in the MADRS Total Score from Baseline. Baseline and Week 8. MADRS Remission at Week 8, with Remission Defined as a MADRS Total Score <= 10 8 Weeks. Change from Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment 8 Weeks. Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment 8 Weeks. Change from Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment 8 Weeks. | — |
Outcome results
None listed