Major depressive disorder(MDD)
Conditions
Interventions
None listed
Sponsors
Takeda Pharmaceutical Company Limited.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1.Outpatients 2.Patients aged between 18 and 65 years at the time of informed consent 3.Patients with a current or new diagnosis of major depressive episode according to Diagnostic and Statistical manual of Mental Disorders-IV (DSM-IV-TR); diagnosis will be confirmed through the MINI International Neuropsychiatric Interview (MINI questionnaire) (Major Depressive Episode module). 4.Patients initiating a new antidepressant monotherapy (tricyclic or tetracyclic antidepressant, SSRI, SNRI, NaSSA) at the baseline visit (whether as first line or switch of antidepressant therapy) as decided by the investigator. 5.Patients who, in the opinion of the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements. 6.Patients who can sign and date an informed consent form prior to the conduction of the clinical research procedures. 7.Patients who are capable of reading and understanding questionnaire
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in this study. 1.Patients who have a concurrent diagnosis or past history of any of the following conditions: Schizophrenia or other psychotic disorders .Bipolar disorders .Dementia or any other neurodegenerative disease .Substance dependence, including alcohol and other drugs, excluding mild and moderate nicotine dependence. Severe nicotine dependence will be excluded. .Any psychiatric disorder due to a general medical condition or substances 2.Patients prescribed with more than 1 antidepressant on the day of the baseline visit (combination of 2 or more antidepressants) 3.Patients prescribed antipsychotic on the day of the baseline visit (augmentation of the antidepressant prescription with an antipsychotic) 4.Patients prescribed mood stabilizers on the day of the baseline visit (augmentation of the antidepressant prescription with a mood stabilizer) 5.Patients having current treatment with electroconvulsive therapy (ECT) or repeated transcranial magnetic stimulation (rTMS) 6.Pregnant women, women breast feeding at the start of the research 7.Patients presenting acute suicidality in the investigator's opinion 8.Patients currently enrolled in an interventional clinical research such as clinical trial 9.Member of the research personnel or their immediate families, or subordinates (or immediate family member of a subordinate) to any of the research personnel. 10.Patient who has previously been enrolled in this research 11.Patients who, in the opinion of the investigator, unlikely to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in digit symbol substitution test (DSST) and Montgomery-Asberg depression scale (MADRS) after 2 and 6 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of patients with cognitive dysfunction using multiple measures (DSST, Item 6 of MADRS and PDQ-D) and depressive symptoms (MADRS) in patients with MDD at baseline, after 2 and 6 months of treatment. The association between cognitive dysfunction and psychosocial function in patients with MDD at baseline, after 2 and 6 months of treatment. Comparison of quality of life and resource uses between MDD patients with different levels of cognitive dysfunction at baseline, after 2 and 6 months of treatment. | — |
Countries
Japan
Contacts
Public ContactKotaro Senuki
Sogo Rinsho Medefi Company Limited. Business promotion department
Outcome results
None listed