Major depressive disorder
Conditions
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The subject has completed the double-blind treatment period of the preceding study (CCT-003) 2.The subject signs and dates a written, informed consent form for this study, different from that for the preceding study (CCT-003). 3.The subject has CGI-S score improved at least one point at completion of the 8-week double-blind treatment period compared to the Baseline Visit in the preceding study (CCT-003). 4.In the opinion of the investigator, the subject appears to benefit from long-term treatment of Lu AA21004.
Exclusion criteria
Exclusion criteria: 1.The subject was diagnosed with the following disorder or symptom in the preceding study (CCT-003): -Any current psychiatric disorder other than MDD as defined in a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR). -Any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR. -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 II disorder that might compromise this study. 2.The subject is at significant risk of suicide, or had a score >=5 on Item 10 (suicidal thoughts) of the MADRS or attempted suicides during the preceding study (CCT-003)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events 52 Weeks:Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug. Number of Participants With Markedly Abnormal Laboratory Values Baseline and Weeks 4, 12, 24, 36, 48, and 52:The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Significant Change from Baseline in Body Weight Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52:Change from Baseline in Participant's Weight Measured Throughout Study. Change from Baseline in Vital Signs 52 Weeks:Vital signs will include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). Change from Baseline in Electrocardiograms Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52:Change from baseline in electrocardiograms measured throughout study. Clinically Significant Change From Baseline in Physical Examination Findings 52 Weeks:Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) other. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at each time point Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52:The change between MADRS score at week 8 or final visit relative to baseline. MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms. Change from baseline in the Clinical Global Impression Scale-Severity (CGI-S) score at each time point Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52:The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator:"Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). Higher scores indicate greater severity of illness. Change from baseline in the Clinical Global Impression - Improvement (CGI-I) score at each time point Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52:The CGI-I assesses the clinician's impression of the subject's state of mental illness improvement and consists of one question for the investigator:"Compared to his condition at the start of the study, <how much has this patient changed?" which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. | — |
Outcome results
None listed